Trial Outcomes & Findings for Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women (NCT NCT03296527)

Results Overview

Defined as at least one intrauterine viable fetus 10-11 weeks after transfer.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1011 participants

Primary outcome timeframe

10-11 weeks after transfer

Results posted on

2023-08-24

Participant Flow

A total of 26 investigational sites randomized participants to the trial: 16 in mainland China, 4 in South Korea, 4 in Taiwan and 2 in Vietnam between Dec 2017 to Jan 2020.

A total of 1167 participants were screened, wherein, 1011 participants met the eligibility criteria and were randomized. Of these, 1009 participants were exposed to the investigational medicinal product (IMP): 499 participants were exposed to FE 999049 and 510 participants were exposed to GONAL-F. A total of 923 participants completed the trial.

Participant milestones

Participant milestones
Measure	FE 000049 (Follitropin Delta) FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days
Overall Study STARTED	500	511
Overall Study Full Analysis Set	499	510
Overall Study COMPLETED	465	458
Overall Study NOT COMPLETED	35	53

Reasons for withdrawal

Reasons for withdrawal
Measure	FE 000049 (Follitropin Delta) FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days
Overall Study Adverse Event	15	33
Overall Study Protocol Deviation	4	0
Overall Study Participant withdrew consent	3	1
Overall Study Discontinuations due to risk of ovarian hyperstimulation syndrome [OHSS]	9	14
Overall Study Discontinuations due to withdrawal from trial	2	3
Overall Study Discontinuations due to thin endometrium or poor endometrial receptivity	0	2
Overall Study Discontinuation due to liquid in uterus	1	0
Overall Study Discontinuation due to risk of Human Immunodeficiency Virus	1	0

Baseline Characteristics

Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	Total n=1009 Participants Total of all reporting groups
Age, Continuous	31.1 years STANDARD_DEVIATION 3.7 • n=5 Participants	31.2 years STANDARD_DEVIATION 3.8 • n=7 Participants	31.1 years STANDARD_DEVIATION 3.7 • n=5 Participants
Age, Customized <35	394 years n=5 Participants	396 years n=7 Participants	790 years n=5 Participants
Age, Customized 35-37	85 years n=5 Participants	86 years n=7 Participants	171 years n=5 Participants
Age, Customized 38-40	20 years n=5 Participants	28 years n=7 Participants	48 years n=5 Participants
Sex: Female, Male Female	499 Participants n=5 Participants	510 Participants n=7 Participants	1009 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	499 Participants n=5 Participants	510 Participants n=7 Participants	1009 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	379 Participants n=5 Participants	381 Participants n=7 Participants	760 Participants n=5 Participants
Race/Ethnicity, Customized South Korean	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized Vietnamese	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Race/Ethnicity, Customized Taiwanese	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Region of Enrollment China	378 participants n=5 Participants	381 participants n=7 Participants	759 participants n=5 Participants
Region of Enrollment South Korea	21 participants n=5 Participants	25 participants n=7 Participants	46 participants n=5 Participants
Region of Enrollment Vietnam	49 participants n=5 Participants	51 participants n=7 Participants	100 participants n=5 Participants
Region of Enrollment Taiwan	51 participants n=5 Participants	53 participants n=7 Participants	104 participants n=5 Participants
Body Mass Index (BMI)	21.8 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants	21.8 kg/m^2 STANDARD_DEVIATION 2.8 • n=7 Participants	21.8 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: 10-11 weeks after transfer

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Defined as at least one intrauterine viable fetus 10-11 weeks after transfer.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Ongoing Pregnancy Rate	31.3 percentage of participants	25.7 percentage of participants

SECONDARY outcome

Timeframe: 13-15 days after transfer

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Defined as positive βhCG test 13-15 days after transfer.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate	41.7 percentage of participants	35.3 percentage of participants

SECONDARY outcome

Timeframe: 5-6 weeks after transfer

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Defined as at least one gestational sac 5-6 weeks after transfer.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Clinical Pregnancy Rate	36.1 percentage of participants	31.2 percentage of participants

SECONDARY outcome

Timeframe: 5-6 weeks after transfer

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Vital Pregnancy Rate	32.3 percentage of participants	28.0 percentage of participants

SECONDARY outcome

Timeframe: 5-6 weeks after transfer

Population: Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryo.

Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=548 Embryos transferred FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=546 Embryos transferred GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Implantation Rate	35.6 percentage of sacs/embryos transferred	31.3 percentage of sacs/embryos transferred

SECONDARY outcome

Timeframe: 10-11 weeks after transfer

Population: Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryos.

Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=548 Embryos transferred FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=546 Embryos transferred GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Ongoing Implantation Rate	30.7 % of viable fetus/embryos transferred	25.8 % of viable fetus/embryos transferred

SECONDARY outcome

Timeframe: Oocyte retrieval visit

Population: The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response.

Extreme ovarian response defined as \<4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as \<4 oocytes retrieved.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=495 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=507 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With Extreme Ovarian Responses <4 or >=15 oocytes retrieved	30.3 percentage of participants	35.1 percentage of participants
Proportion of Subjects With Extreme Ovarian Responses <4 or >=20 oocytes retrieved	17.4 percentage of participants	18.9 percentage of participants

SECONDARY outcome

Timeframe: Up to 9 days after triggering of final follicular maturation

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS Early OHSS (any grade)	4.0 percentage of participants	6.5 percentage of participants
Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS Early OHSS (moderate/severe)	3.6 percentage of participants	4.7 percentage of participants
Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS Any preventive intervention	1.2 percentage of participants	3.5 percentage of participants
Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS Early OHSS (any grade) and/or preventive interventions	5.0 percentage of participants	9.6 percentage of participants
Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS Early OHSS (moderate/severe) and/or preventive interventions	4.6 percentage of participants	7.8 percentage of participants

SECONDARY outcome

Timeframe: End-of-stimulation visit (up to 20 days) or transfer visit

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk Cycle cancellation due to poor response	3.4 percentage of participants	0.8 percentage of participants
Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk Cycle cancellation due to excessive response	0 percentage of participants	0 percentage of participants
Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk Transfer cancellation due to excessive ovarian response/ OHSS risk	5.2 percentage of participants	12.4 percentage of participants
Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk Cycle cancellation: poor/excessive response, or transfer cancellation excessive response/OHSS risk	8.6 percentage of participants	13.1 percentage of participants

SECONDARY outcome

Timeframe: On stimulation Day 6

Population: The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Counted by ultrasound for the right and left ovary for each participant.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=498 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=509 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Number of Follicles on Stimulation Day 6 Follicles >= 10 mm	5.4 number of follicles Standard Deviation 3.5	6.4 number of follicles Standard Deviation 4.0
Number of Follicles on Stimulation Day 6 Follicles >= 12 mm	2.3 number of follicles Standard Deviation 2.2	2.9 number of follicles Standard Deviation 2.5
Number of Follicles on Stimulation Day 6 Follicles >= 15 mm	0.3 number of follicles Standard Deviation 0.7	0.3 number of follicles Standard Deviation 0.8
Number of Follicles on Stimulation Day 6 Follicles >= 17 mm	0.1 number of follicles Standard Deviation 0.3	0.0 number of follicles Standard Deviation 0.2

SECONDARY outcome

Timeframe: At end-of-stimulation (up to 20 stimulation days)

Population: The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Counted by ultrasound for the right and left ovary for each participant.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=494 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=509 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Number of Follicles At End-of-stimulation (up to 20 Stimulation Days) Follicles >= 10 mm	12.4 number of follicles Standard Deviation 5.6	14.2 number of follicles Standard Deviation 6.6
Number of Follicles At End-of-stimulation (up to 20 Stimulation Days) Follicles >= 12 mm	10.3 number of follicles Standard Deviation 4.9	11.9 number of follicles Standard Deviation 5.7
Number of Follicles At End-of-stimulation (up to 20 Stimulation Days) Follicles >= 15 mm	6.5 number of follicles Standard Deviation 3.2	7.5 number of follicles Standard Deviation 3.5
Number of Follicles At End-of-stimulation (up to 20 Stimulation Days) Follicles >= 17 mm	4.1 number of follicles Standard Deviation 1.8	4.5 number of follicles Standard Deviation 2.0

SECONDARY outcome

Timeframe: On stimulation Day 6

Population: The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Counted by ultrasound for the right and left ovary for each participant.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=461 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=493 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Size of Follicles on Stimulation Day 6 Largest follicle (mm)	13.1 mm Standard Deviation 2.0	13.2 mm Standard Deviation 1.8
Size of Follicles on Stimulation Day 6 Average follicle size (mm)	11.5 mm Standard Deviation 1.0	11.6 mm Standard Deviation 1.0
Size of Follicles on Stimulation Day 6 Average size of 3 largest follicles (mm)	12.5 mm Standard Deviation 1.6	12.6 mm Standard Deviation 1.4

SECONDARY outcome

Timeframe: At end-of-stimulation (up to 20 stimulation days)

Population: The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Counted by ultrasound for the right and left ovary for each participant.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=490 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=509 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Size of Follicles At End-of-stimulation (up to 20 Stimulation Days) Largest follicle (mm)	19.8 mm Standard Deviation 1.9	19.8 mm Standard Deviation 1.6
Size of Follicles At End-of-stimulation (up to 20 Stimulation Days) Average follicle size (mm)	15.0 mm Standard Deviation 1.3	15.1 mm Standard Deviation 1.1
Size of Follicles At End-of-stimulation (up to 20 Stimulation Days) Average size of 3 largest follicles (mm)	18.6 mm Standard Deviation 1.4	18.7 mm Standard Deviation 1.1

SECONDARY outcome

Timeframe: On the day of oocyte retrieval (36 h [±2h] after triggering of final follicular maturation)

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

The number of oocytes retrieved was recorded at the oocyte retrieval visit.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Number of Oocytes Retrieved	10.0 oocytes retrieved Standard Deviation 6.1	12.4 oocytes retrieved Standard Deviation 7.3

SECONDARY outcome

Timeframe: On the day of oocyte retrieval

Population: The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response.

Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the \<4 oocytes group.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=495 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=507 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved <4 (low response)	11.3 percentage of participants	4.7 percentage of participants
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved 4 -7 (moderate response)	23.0 percentage of participants	22.3 percentage of participants
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved 8-14 (targeted response)	46.7 percentage of participants	42.6 percentage of participants
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved 15-19(hyperresponse)	12.9 percentage of participants	16.2 percentage of participants
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved >=20 (severe hyperresponse)	6.1 percentage of participants	14.2 percentage of participants

SECONDARY outcome

Timeframe: Prior to insemination

Population: The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with all oocytes inseminated using ICSI.

The percentage of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using intracytoplasmic sperm injection (ICSI) are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=223 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=232 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Percentage of Metaphase II (MII) Oocytes	79.5 percentage of oocytes Standard Deviation 17.6	77.8 percentage of oocytes Standard Deviation 17.7

SECONDARY outcome

Timeframe: On Day 1 after oocyte retrieval

Population: Participants with oocytes retrieved.

The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=477 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=502 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Fertilization Rate	63.5 percentage of fertilized oocytes Standard Deviation 22.9	63.9 percentage of fertilized oocytes Standard Deviation 21.0

SECONDARY outcome

Timeframe: On Day 3 after oocyte retrieval

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Number and Quality of Embryos Number of embryos	7.0 embryos Standard Deviation 4.6	8.7 embryos Standard Deviation 5.5
Number and Quality of Embryos Number of good-quality embryos	4.1 embryos Standard Deviation 3.6	5.2 embryos Standard Deviation 4.3

SECONDARY outcome

Timeframe: On stimulation Day 6

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of LH were drawn. The median and inter-quartile range (IQR) of LH levels on stimulation Day 6 are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=496 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=508 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Luteinizing Hormone (LH)	2.6 IU/L Interval 1.7 to 4.7	3.1 IU/L Interval 1.9 to 6.8

SECONDARY outcome

Timeframe: End-of-stimulation (up to 20 stimulation days)

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels at end-of-stimulation are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=492 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=503 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of LH	1.8 IU/L Interval 1.1 to 2.9	2.0 IU/L Interval 1.2 to 3.1

SECONDARY outcome

Timeframe: On stimulation Day 6

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation Day 6 are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=497 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=509 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Estradiol	2240.7 pmol/L Interval 1325.8 to 3641.1	2885.9 pmol/L Interval 1729.4 to 4492.1

SECONDARY outcome

Timeframe: End-of-stimulation (up to 20 stimulation days)

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels at end-of-stimulation are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=491 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=504 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Estradiol	7429.3 pmol/L Interval 4786.2 to 10439.8	9055.8 pmol/L Interval 6214.2 to 12964.3

SECONDARY outcome

Timeframe: On stimulation Day 6

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation Day 6 are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=497 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=507 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Progesterone	1.7 nmol/L Interval 0.8 to 2.6	1.9 nmol/L Interval 0.8 to 2.9

SECONDARY outcome

Timeframe: End-of-stimulation (up to 20 stimulation days)

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels at end-of-stimulation are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=490 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=502 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Progesterone	2.4 nmol/L Interval 1.7 to 3.5	3.2 nmol/L Interval 2.2 to 4.4

SECONDARY outcome

Timeframe: On stimulation Day 6

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of inhibin A. The median and IQR of inhibin A levels on stimulation Day 6 are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=496 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=508 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Inhibin A	107.9 ng/L Interval 61.6 to 163.5	129.1 ng/L Interval 84.6 to 203.6

SECONDARY outcome

Timeframe: End-of-stimulation (up to 20 stimulation days)

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels at end-of-stimulation are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=491 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=504 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Inhibin A	361.7 ng/L Interval 252.8 to 525.6	447.4 ng/L Interval 307.5 to 630.9

SECONDARY outcome

Timeframe: On stimulation Day 6

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels on stimulation Day 6 are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=445 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=452 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Inhibin B	740.0 ng/L Interval 481.0 to 1069.0	901.0 ng/L Interval 588.0 to 1317.5

SECONDARY outcome

Timeframe: End-of-stimulation (up to 20 stimulation days)

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels at end-of-stimulation are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=445 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=449 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Inhibin B	1020.0 ng/L Interval 689.0 to 1488.0	1101.0 ng/L Interval 738.0 to 1665.0

SECONDARY outcome

Timeframe: On stimulation Day 6

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation Day 6 are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=497 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=509 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of Follicle-stimulating Hormone (FSH)	11.6 IU/L Interval 9.5 to 14.8	11.2 IU/L Interval 9.5 to 13.3

SECONDARY outcome

Timeframe: End-of-stimulation (up to 20 stimulation days)

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at end-of-stimulation are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=491 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=504 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of FSH	11.3 IU/L Interval 9.2 to 14.4	12.2 IU/L Interval 10.4 to 15.2

SECONDARY outcome

Timeframe: At oocyte retrieval

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at oocyte retrieval are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=478 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=503 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Circulating Concentrations of FSH	5.6 IU/L Interval 4.5 to 7.1	5.5 IU/L Interval 4.4 to 6.9

SECONDARY outcome

Timeframe: Up to 20 stimulation days

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Calculated by start dates, end dates and daily dose of IMP.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Total Gonadotropin Dose	77.5 microgram of dose Standard Deviation 24.4	109.9 microgram of dose Standard Deviation 32.9

SECONDARY outcome

Timeframe: Up to 20 stimulation days

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Investigator-requested decreases and increases of the gonadotropin dose were captured during the stimulation period.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments	57.1 percentage of participants	55.3 percentage of participants

SECONDARY outcome

Timeframe: Up to 20 stimulation days

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

Calculated by start dates and end dates.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Number of Stimulation Days	9.2 days Standard Deviation 1.9	8.7 days Standard Deviation 1.6

SECONDARY outcome

Timeframe: From screening up to end-of-trial (up to approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=449 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Number of Participants With Adverse Events	46.3 percentage of participants	43.1 percentage of participants

SECONDARY outcome

Timeframe: From screening up to end-of-trial (up to approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

The intensity of adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Intensity of Adverse Events Severe adverse events	3.6 percentage of participants	1.8 percentage of participants
Intensity of Adverse Events Mild adverse events	40.1 percentage of participants	37.8 percentage of participants
Intensity of Adverse Events Moderate adverse events	7.4 percentage of participants	5.9 percentage of participants

SECONDARY outcome

Timeframe: From screening up to end-of-trial (up to approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase and Gamma glutamyl transferase.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=494 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=506 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase Alanine aminotransferase	3.9 IU/L Standard Deviation 13.8	4.6 IU/L Standard Deviation 16.7
Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase Alkaline phosphatase	-2.9 IU/L Standard Deviation 8.2	-2.7 IU/L Standard Deviation 8.0
Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase Aspartate aminotransferase	0.7 IU/L Standard Deviation 7.1	1.2 IU/L Standard Deviation 13.0
Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase Gamma glutamyl transferase	1.1 IU/L Standard Deviation 6.6	1.1 IU/L Standard Deviation 10.2

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, Blood urea nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=494 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=506 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium Bicarbonate	-0.83 mmol/L Standard Deviation 2.52	-0.72 mmol/L Standard Deviation 2.51
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium Blood urea nitrogen	-0.27 mmol/L Standard Deviation 1.12	-0.23 mmol/L Standard Deviation 1.11
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium Calcium	-0.010 mmol/L Standard Deviation 0.089	0.000 mmol/L Standard Deviation 0.081
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium Chloride	-0.3 mmol/L Standard Deviation 2.3	-0.3 mmol/L Standard Deviation 2.4
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium Cholesterol	0.218 mmol/L Standard Deviation 0.537	0.260 mmol/L Standard Deviation 0.549
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium Glucose	-0.01 mmol/L Standard Deviation 0.94	-0.01 mmol/L Standard Deviation 0.91
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium Phosphate	0.037 mmol/L Standard Deviation 0.166	0.023 mmol/L Standard Deviation 0.169
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium Potassium	0.03 mmol/L Standard Deviation 0.34	0.04 mmol/L Standard Deviation 0.33
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium Sodium	-1.8 mmol/L Standard Deviation 2.6	-1.7 mmol/L Standard Deviation 2.5

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and Protein.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=494 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=506 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Albumin	-2.0 g/L Standard Deviation 3.1	-1.6 g/L Standard Deviation 3.0
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Protein	-2.3 g/L Standard Deviation 4.6	-1.5 g/L Standard Deviation 4.5

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameter including: Lactate dehydrogenase.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=452 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=455 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Clinical Chemistry Parameter: Lactate Dehydrogenase	-3.0 U/L Standard Deviation 17.0	-0.9 U/L Standard Deviation 18.9

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of clinical chemistry parameter including: Direct bilirubin, Bilirubin, Creatinine, Urate.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=494 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=506 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate Direct bilirubin	-0.3 umol/L Standard Deviation 0.8	-0.2 umol/L Standard Deviation 0.8
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate Bilirubin	-1.3 umol/L Standard Deviation 3.6	-1.0 umol/L Standard Deviation 3.5
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate Creatinine	-3.4 umol/L Standard Deviation 9.0	-3.5 umol/L Standard Deviation 8.5
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate Urate	-18.8 umol/L Standard Deviation 54.1	-17.9 umol/L Standard Deviation 53.5

SECONDARY outcome

Timeframe: End-of-stimulation visit and end-of-trial visit

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, phosphate.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=494 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=505 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate Alanine aminotransferase (IU/L) (End-of-stimulation)	0.2 percentage of participants	0.2 percentage of participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate Aspartate aminotransferase (IU/L) (End-of-stimulation)	0 percentage of participants	0.2 percentage of participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate Phosphate (mmol/L) (End-of-stimulation)	0.2 percentage of participants	0.0 percentage of participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate Alanine aminotransferase (IU/L) (End-of-trial)	0.4 percentage of participants	0.6 percentage of participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate Bicarbonate (mmol/L) (End-of-trial)	1.3 percentage of participants	0.8 percentage of participants
Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate Calcium (mmol/L) (End-of-trial)	0 percentage of participants	0.2 percentage of participants

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameter including: Erythrocytes.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=489 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=503 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Haematology Parameter: Erythrocytes	-0.13 10^12 cells/L Standard Deviation 0.31	-0.09 10^12 cells/L Standard Deviation 0.27

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters including: Leukocytes and Platelets.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=489 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=503 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Haematology Parameters: Leukocytes and Platelets Leukocytes	1.161 10^9 cells/L Standard Deviation 2.232	0.996 10^9 cells/L Standard Deviation 2.099
Change From Baseline in Haematology Parameters: Leukocytes and Platelets Platelets	19.9 10^9 cells/L Standard Deviation 41.7	23.8 10^9 cells/L Standard Deviation 40.6

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=489 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=503 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Haematology Parameter: Haemoglobin	-2.9 g/L Standard Deviation 8.9	-1.7 g/L Standard Deviation 7.9

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameter including: Haematocrit.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=480 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=491 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Haematology Parameter: Haematocrit	-0.012 Ratio Standard Deviation 0.033	-0.008 Ratio Standard Deviation 0.030

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=480 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=491 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Volume	0.0 Femtoliters Standard Deviation 3.3	0.1 Femtoliters Standard Deviation 3.2

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=489 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=503 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin	0.3 picogram Standard Deviation 0.9	0.2 picogram Standard Deviation 0.8

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=480 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=491 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin Concentration	0.2 mmol/L Standard Deviation 0.8	0.1 mmol/L Standard Deviation 0.8

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, Eosinophils/leukocytes, Lymphocytes/leukocytes, Monocytes/leukocytes and Neutrophils/leukocytes.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=489 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=502 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes Monocytes/leukocytes	-0.16 percentage Standard Deviation 1.52	-0.04 percentage Standard Deviation 1.66
Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes Basophils/leukocytes	-0.01 percentage Standard Deviation 0.37	0.02 percentage Standard Deviation 0.36
Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes Eosinophils/leukocytes	-0.01 percentage Standard Deviation 1.08	-0.07 percentage Standard Deviation 1.04
Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes Lymphocytes/leukocytes	-2.05 percentage Standard Deviation 9.18	-1.39 percentage Standard Deviation 9.16
Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes Neutrophils/leukocytes	2.20 percentage Standard Deviation 10.03	1.50 percentage Standard Deviation 9.89

SECONDARY outcome

Timeframe: End-of-stimulation visit and end-of-trial visit

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation and end-of-trial values for leukocytes and lymphocytes/leukocytes.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=474 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=487 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes Leukocytes (10^9 cells/L) (End-of-stimulation)	0.7 percentage of participants	0 percentage of participants
Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes Lymphocytes/leukocytes (%) (End-of-stimulation)	0.4 percentage of participants	0.2 percentage of participants
Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes Leukocytes (10^9 cells/L) (End-of-trial)	0.7 percentage of participants	0 percentage of participants
Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes Lymphocytes/leukocytes (%) (End-of-trial)	0.6 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs).

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Number of Immune-related Adverse Events	0 events	0 events

SECONDARY outcome

Timeframe: End-of-stimulation (up to 20 stimulation days)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Frequency of Injection Site Reactions	23.2 percentage of participants	21.6 percentage of participants

SECONDARY outcome

Timeframe: End-of-stimulation (up to 20 stimulation days)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Assessed by the participant during the stimulation period as mild, moderate or severe. Participants are tabulated according to the highest severity of their reported injection site reactions.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Intensity of Injection Site Reactions Mild injection site reaction	21.6 percentage of participants	21.2 percentage of participants
Intensity of Injection Site Reactions Moderate injection site reaction	1.6 percentage of participants	0.4 percentage of participants
Intensity of Injection Site Reactions Severe injection site reaction	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 28 days after end of the stimulation period

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Measured by presence of anti-FSH antibodies.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity Treatment-induced anti-FSH antibodies (Overall)	1.40 percentage of participants Interval 0.57 to 2.87	0.98 percentage of participants Interval 0.32 to 2.27
Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity Treatment-induced anti-FSH antibodies with neutralizing capacity	0 percentage of participants For participants with treatment-induced anti-FSH antibodies, none of the antibodies were of neutralizing capacity at any sampling time point.	0 percentage of participants For participants with treatment-induced anti-FSH antibodies, none of the antibodies were of neutralizing capacity at any sampling time point.

SECONDARY outcome

Timeframe: From screening up to end-of-trial (approximately 5.5 months)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

The intensity of immune-related adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Intensity of Immune-related Adverse Events Severe	0 events	0 events
Intensity of Immune-related Adverse Events Moderate	0 events	0 events
Intensity of Immune-related Adverse Events Mild	0 events	0 events

SECONDARY outcome

Timeframe: Up to 20 stimulation days

Population: The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.

For each participant the reason for cycle cancellation will be recorded.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen Adverse event (including immune-related adverse events)	0 percentage of participants	0.2 percentage of participants
Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen Technical malfunctions of the administration pen	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: After 9 days post triggering of final follicular maturation

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Late OHSS was defined as OHSS with onset \>9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Subjects With Late OHSS Late OHSS (Any grade)	4.0 percentage of participants	2.0 percentage of participants
Proportion of Subjects With Late OHSS Late OHSS (Moderate/severe)	3.6 percentage of participants	1.8 percentage of participants

SECONDARY outcome

Timeframe: End-of-trial

Population: The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=156 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=131 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Participants With Multi-fetal Gestation	7.7 percentage of participants	9.9 percentage of participants

SECONDARY outcome

Timeframe: End-of-trial

Population: The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.

Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention). Frequency of early pregnancy losses are presented.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=208 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=180 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Participants With Early Pregnancy Losses	25.0 percentage of participants	27.2 percentage of participants

SECONDARY outcome

Timeframe: End-of-stimulation (up to 20 stimulation days)

Population: The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Incidences of technical malfunctions of the administration pen were recorded.

Outcome measures

Outcome measures
Measure	FE 000049 (Follitropin Delta) n=499 Participants FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 Participants GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Proportion of Participants With Technical Malfunctions of the Administration Pen	0.4 percentage of participants	0 percentage of participants

Adverse Events

FE 000049 (Follitropin Delta)

Serious events: 30 serious events

Other events: 97 other events

Deaths: 0 deaths

GONAL-F (Follitropin Alfa)

Serious events: 18 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FE 000049 (Follitropin Delta) n=499 participants at risk FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 participants at risk GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Gastrointestinal disorders Enteritis	0.20% 1/499 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.00% 0/510 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Infections and infestations Bartholin's abscess	0.00% 0/499 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.20% 1/510 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Infections and infestations Bronchitis	0.20% 1/499 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.00% 0/510 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Infections and infestations Influenza	0.00% 0/499 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.20% 1/510 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Infections and infestations Pelvic inflammatory disease	0.00% 0/499 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.20% 1/510 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	1.6% 8/499 • Number of events 8 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.20% 1/510 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.60% 3/499 • Number of events 3 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.78% 4/510 • Number of events 4 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.80% 4/499 • Number of events 4 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.39% 2/510 • Number of events 2 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Pregnancy, puerperium and perinatal conditions Biochemical pregnancy	0.20% 1/499 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.00% 0/510 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.20% 1/499 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.00% 0/510 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Pregnancy, puerperium and perinatal conditions Vomiting in pregnancy	0.00% 0/499 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.20% 1/510 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	2.2% 11/499 • Number of events 11 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	1.6% 8/510 • Number of events 8 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Reproductive system and breast disorders Adnexal torsion	0.20% 1/499 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	0.20% 1/510 • Number of events 1 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Other adverse events

Other adverse events
Measure	FE 000049 (Follitropin Delta) n=499 participants at risk FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.	GONAL-F (Follitropin Alfa) n=510 participants at risk GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	5.8% 29/499 • Number of events 29 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	6.9% 35/510 • Number of events 35 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Reproductive system and breast disorders Pelvic discomfort	5.0% 25/499 • Number of events 26 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	5.5% 28/510 • Number of events 30 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Pregnancy, puerperium and perinatal conditions Biochemical pregnancy	5.0% 25/499 • Number of events 25 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	4.1% 21/510 • Number of events 21 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	5.0% 25/499 • Number of events 25 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.	3.5% 18/510 • Number of events 20 • Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months). Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set. The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.

Additional Information

Global Clinical Compliance

Ferring Pharmaceuticals

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Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
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