Trial Outcomes & Findings for Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART) (NCT NCT01185704)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

136 participants

Primary outcome timeframe

r-hCG day (end of stimulation cycle [approximately 15 days])

Results posted on

2014-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Day 1 Protocol Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Study STARTED	68	68
Overall Study Treated	65	65
Overall Study COMPLETED	55	60
Overall Study NOT COMPLETED	13	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Day 1 Protocol Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Overall Study Randomized but not treated	3	3
Overall Study Lack of ovarian response	5	1
Overall Study Ovarian hyperstimulation syndrome risk	5	3
Overall Study Ectopic pregnancy	0	1

Baseline Characteristics

Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Day 1 Protocol n=65 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Total n=130 Participants Total of all reporting groups
Age, Continuous	29.7 years STANDARD_DEVIATION 2.9 • n=5 Participants	29.7 years STANDARD_DEVIATION 3.3 • n=7 Participants	29.7 years STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	65 Participants n=7 Participants	130 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: r-hCG day (end of stimulation cycle [approximately 15 days])

Population: Intent to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N" (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=58 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=62 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Estradiol (E2) Levels on r-hCG Day	1668.86 picogram/milliliter (pg/mL) Standard Deviation 862.62	1672.80 picogram/milliliter (pg/mL) Standard Deviation 835.49

SECONDARY outcome

Timeframe: Day 1

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. N" (number of participants analyzed) signifies those participants who were evaluable for this measure. Here "n" signifies those participants who were evaluated for specified category.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=58 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=62 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels LH levels (n=58, 62)	4.87 International unit/liter (IU/L) Standard Deviation 4.62	6.84 International unit/liter (IU/L) Standard Deviation 3.99
Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels FSH levels (n=57, 59)	4.98 International unit/liter (IU/L) Standard Deviation 1.54	6.69 International unit/liter (IU/L) Standard Deviation 10.29

SECONDARY outcome

Timeframe: Day 1

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=60 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=63 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Serum Estradiol (E2) Levels	30.42 pg/mL Standard Deviation 14.06	68.79 pg/mL Standard Deviation 116.09

SECONDARY outcome

Timeframe: Day 1

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=59 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=62 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Serum Progesterone (P4) Levels	0.83 nanomolar/liter (nmol/L) Standard Deviation 0.72	0.97 nanomolar/liter (nmol/L) Standard Deviation 1.82

SECONDARY outcome

Timeframe: Day 0

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=63 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=64 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Anti Mullerian Hormone (AMH) Levels	6.27 nanogram/milliliter (ng/mL) Standard Deviation 4.40	7.18 nanogram/milliliter (ng/mL) Standard Deviation 4.11

SECONDARY outcome

Timeframe: r-hCG day (end of stimulation cycle [approximately 15 days])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=58 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=61 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day	3.55 follicles Standard Deviation 2.20	2.49 follicles Standard Deviation 1.99

SECONDARY outcome

Timeframe: Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.

Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=65 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Number and Quality of Oocytes Retrieved Total number of oocytes	7.48 oocytes Standard Deviation 5.21	8.11 oocytes Standard Deviation 5.55
Number and Quality of Oocytes Retrieved Mature oocytes	2.52 oocytes Standard Deviation 4.07	3.72 oocytes Standard Deviation 4.43
Number and Quality of Oocytes Retrieved Fractured oocytes	0.09 oocytes Standard Deviation 0.34	0.11 oocytes Standard Deviation 0.44
Number and Quality of Oocytes Retrieved Immature oocytes	0.98 oocytes Standard Deviation 2.29	1.38 oocytes Standard Deviation 2.55
Number and Quality of Oocytes Retrieved Inseminated oocytes	3.06 oocytes Standard Deviation 4.14	4.52 oocytes Standard Deviation 4.66

SECONDARY outcome

Timeframe: Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=64 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)	1462.50 international unit (IU) Standard Deviation 537.85	1221.35 international unit (IU) Standard Deviation 478.31

SECONDARY outcome

Timeframe: Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=56 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=61 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Percentage of Fertilized Oocytes Retrieved	46.22 percent fertilized oocytes Standard Deviation 30.66	46.86 percent fertilized oocytes Standard Deviation 30.54

SECONDARY outcome

Timeframe: Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.

Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=65 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Number of Embryos	3.18 embryos Standard Deviation 3.18	3.60 embryos Standard Deviation 3.27

SECONDARY outcome

Timeframe: Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.

Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=65 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Number of Blastocysts	0.26 blastocysts Standard Deviation 1.05	0.20 blastocysts Standard Deviation 0.90

SECONDARY outcome

Timeframe: Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.

Embryo transfer is the procedure in which one or more embryos are placed in the uterus.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=65 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Number of Transferred Embryos	0.95 transferred embryos Standard Deviation 0.74	1.02 transferred embryos Standard Deviation 0.74

SECONDARY outcome

Timeframe: 5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=46 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=48 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Implantation Rate	36.90 percent sacs per embryo	32.25 percent sacs per embryo

SECONDARY outcome

Timeframe: 10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.

Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=65 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Percentage of Participants With Clinical Pregnancy	20 percentage of participants	20 percentage of participants

SECONDARY outcome

Timeframe: Day 1 up to end of study (15 days post last administration of study drug)

An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.

Outcome measures

Outcome measures
Measure	Day 1 Protocol n=65 Participants Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 Participants Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	11 participants	18 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	2 participants	4 participants

Adverse Events

Day 1 Protocol

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Day 7 Protocol

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Day 1 Protocol n=65 participants at risk Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 participants at risk Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Reproductive system and breast disorders Ovarian Hyperstimulation syndrome	3.1% 2/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	4.6% 3/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.

Other adverse events

Additional Information

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Principal investigator is a sponsor employee
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Restriction type: OTHER

Measure	Day 1 Protocol n=65 participants at risk Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.	Day 7 Protocol n=65 participants at risk Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
Gastrointestinal disorders Abdominal pain	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Gastrointestinal disorders Anal fissure	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Gastrointestinal disorders Nausea	3.1% 2/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Nervous system disorders Headache	9.2% 6/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
General disorders Injection site erythema	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
General disorders Injection site irritation	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
General disorders Injection site burning	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
General disorders Injection site pruritus	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
General disorders Pyrexia	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Reproductive system and breast disorders Ovarian Hyperstimulation syndrome	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	9.2% 6/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Reproductive system and breast disorders Pelvic pain	6.2% 4/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	4.6% 3/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Reproductive system and breast disorders Adnexa uterin pain	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Investigations Oestradiol increased	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Vascular disorders Hot flush	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
General disorders Injection site pain	0.00% 0/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	1.5% 1/65 • Day 1 up to end of study (15 days post last administration of study drug) An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.