Trial Outcomes & Findings for Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle (NCT NCT01071200)

NCT ID: NCT01071200

Last Updated: 2013-12-27

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 133 participants
• Primary outcome timeframe: Baseline (Stimulation day 8 [S8]) until hCG day
• Results posted on: 2013-12-27

Participant Flow

Participant milestones

Measure	FSH + rhLH Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) FSH injection s.c. administered according to investigator's discretion till r-hCG administration day.
Overall Study STARTED	67	66
Overall Study COMPLETED	60	63
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Measure	FSH + rhLH Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) FSH injection s.c. administered according to investigator's discretion till r-hCG administration day.
Overall Study Lack of ovarian response	1	1
Overall Study No fertilization	4	0
Overall Study No oocytes retrieved	1	1
Overall Study Ovarian Hyper Stimulation Syndrome	1	0
Overall Study No viable embryos	0	1

Baseline Characteristics

Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle

Baseline characteristics by cohort

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=66 Participants FSH injection s.c. administered according to investigator's discretion till r-hCG administration day.	Total n=133 Participants Total of all reporting groups
Age, Continuous	35.6 years STANDARD_DEVIATION 2.9 • n=5 Participants	35.0 years STANDARD_DEVIATION 3.8 • n=7 Participants	35.3 years STANDARD_DEVIATION 3.4 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	66 Participants n=7 Participants	133 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: Baseline (Stimulation day 8 [S8]) until hCG day

Population: Modified intention-to-treat (mITT) population included all randomized participants who entered in the experimental phase at S8. Here "N" represents number of participants analyzed for this measure.

Outcome measures

Measure	FSH + rhLH n=64 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=64 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes Baseline (S8)	904.6 IU Standard Deviation 1068.1	703.3 IU Standard Deviation 924.5
Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes Baseline (S8) until hCG day	388.5 IU Standard Deviation 631.3	318.5 IU Standard Deviation 534.0

SECONDARY outcome

Timeframe: Baseline (S8) until hCG day

Population: mITT population included all randomized participants who entered in the experimental phase at S8.

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=65 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose Total r-hLH dose	575.9 IU Standard Deviation 273.0	0 IU Standard Deviation 0
Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose Total FSH dose	1434.0 IU Standard Deviation 678.1	1595.0 IU Standard Deviation 796.4

SECONDARY outcome

Timeframe: Baseline (S8) until hCG day

Population: mITT population included all randomized participants who entered in the experimental phase at S8.

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=65 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Mean Number of Ovarian Stimulation Days	4.6 Days Interval 2.0 to 10.0	4.8 Days Interval 1.0 to 9.0

SECONDARY outcome

Timeframe: Baseline (S8) and hCG day

Population: mITT population included all randomized participants who entered in the experimental phase at S8. Here "N" represents number of participants analyzed and "n" represents the number of participants with plasma E2 levels at specified time points for respective treatment groups.

Outcome measures

Measure	FSH + rhLH n=59 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=59 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day Baseline (n = 59,59)	516.1 picogram/milliter (pg/mL) Standard Deviation 353.6	518.9 picogram/milliter (pg/mL) Standard Deviation 334.2
Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day Change at hCG day (n = 40,47)	1391.6 picogram/milliter (pg/mL) Standard Deviation 743.4	1179.9 picogram/milliter (pg/mL) Standard Deviation 746.5

SECONDARY outcome

Timeframe: 34-36 hours post-hCG (OPU)

Population: mITT population included all randomized participants who entered in the experimental phase at S8.

Mean number of oocytes retrieved on the day of ovum pick up (OPU) was counted. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=65 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Mean Total Number of Retrieved Oocytes	7.0 oocytes Standard Deviation 4.6	7.8 oocytes Standard Deviation 3.9

SECONDARY outcome

Timeframe: 34-36 hours post-hCG (OPU)

Population: mITT population included all randomized participants who entered in the experimental phase at S8. Here "N" represents those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope.

Mean number of metaphase II oocytes was counted for participants undergoing ovum pick up for IntraCytoplasmic Sperm Injection (ICSI). ICSI is a procedure in which a single spermatozoon is injected into the oocyte cytoplasm. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.

Outcome measures

Measure	FSH + rhLH n=59 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=62 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Mean Number of Mature Oocytes (Metaphase II)	5.1 Metaphase II Oocytes Standard Deviation 3.7	5.7 Metaphase II Oocytes Standard Deviation 3.2

SECONDARY outcome

Timeframe: 12-18 day post-hCG and/or Week 7

Population: mITT population included all randomized participants who entered in the experimental phase at S8.

Fertilization rate was measured as the ratio between number of fertilized oocytes and number of inseminated oocytes (maximum 3).

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=65 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Fertilization Rate	0.85 ratio Standard Deviation 0.29	0.89 ratio Standard Deviation 0.20

SECONDARY outcome

Timeframe: Day 3 post-hCG (Embryo transfer [ET])

Population: mITT population included all randomized participants who entered in the experimental phase at S8.

Total number of obtained embryos with maximum 3 inseminated oocytes was calculated.

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=65 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Number of Obtained Embryos	142 embryos	158 embryos

SECONDARY outcome

Timeframe: Day 3 post-hCG (ET)

Population: mITT population included all randomized participants who entered in the experimental phase at S8.

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

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=65 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Number of Transferred Embryos	60 embryos	63 embryos

SECONDARY outcome

Timeframe: 12-18 day post-hCG and/or Week 7

Population: mITT population included all randomized participants who entered in the experimental phase at S8.

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=65 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Percentage of Participants With Pregnancy	29.9 percentage of participants	30.8 percentage of participants

SECONDARY outcome

Timeframe: 12-18 day post-hCG and/or Week 7

Population: mITT population included all randomized participants who entered in the experimental phase at S8.

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

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=65 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Percentage of Participants With Clinical Pregnancy	23.9 percentage of participants	18.5 percentage of participants

SECONDARY outcome

Timeframe: 12-18 day post-hCG and/or Week 7

Population: mITT population included all randomized participants who entered in the experimental phase at S8.

Implantation is the attachment and subsequent penetration by the zona-free blastocyst (usually in the endometrium) that starts five to seven days after fertilization.

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=65 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Percentage of Participants With Implantation	13.38 percentage of participants	11.39 percentage of participants

SECONDARY outcome

Timeframe: Baseline (S8) until 12-18 day post-hCG and/or Week 7

Population: Safety population included all the randomized participants who received at least one dose of the study drug.

OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=66 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) Moderate OHSS	1 participants	0 participants
Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) Severe OHSS	0 participants	0 participants
Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) Mild OHSS	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline (S8) until 12-18 day post-hCG and/or Week 7

Population: Safety population included all the randomized participants who received at least one dose of the study drug.

OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.

Outcome measures

Measure	FSH + rhLH n=67 Participants Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=66 Participants FSH injection administered according to investigator's discretion till r-hCG administration day.
Number of Cycles Cancelled Due to Risk of OHSS	1 cycles	0 cycles

Adverse Events

FSH + rhLH

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Follicle-stimulating Hormone (FSH)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	FSH + rhLH n=67 participants at risk Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=66 participants at risk FSH injection administered according to investigator's discretion till r-hCG administration day.
General disorders Left ectopic pregnancy	0.00% 0/67 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.	1.5% 1/66 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.
General disorders Cerclage	1.5% 1/67 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.	0.00% 0/66 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.
General disorders Renal colic	0.00% 0/67 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.	1.5% 1/66 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.

Other adverse events

Measure	FSH + rhLH n=67 participants at risk Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).	Follicle-stimulating Hormone (FSH) n=66 participants at risk FSH injection administered according to investigator's discretion till r-hCG administration day.
General disorders Ovarian Hyper Stimulation Syndrome	1.5% 1/67 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.	0.00% 0/66 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.
General disorders Urticaria post intake of food (fish)	1.5% 1/67 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.	0.00% 0/66 • AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment. Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study;Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication; Post-Treatment: If the onset date of the AE was post-hCG Days 12 - 18 for participants who completed the study.

Additional Information

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Phone: +49-6151-72-5200

Email: service@merckgroup.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER