Trial Outcomes & Findings for A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age (NCT NCT01075815)

Last Updated: 2014-02-13

Results Overview

Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])

Results posted on

2014-02-13

Participant Flow

One out of 76 randomized participants did not receive study medication.

Participant milestones

Participant milestones
Measure	rFSH + rhLH Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Overall Study STARTED	40	35
Overall Study COMPLETED	30	31
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Reasons for withdrawal
Measure	rFSH + rhLH Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Overall Study Withdrawal before r-hCG administration	6	1
Overall Study Withdrawal between rhCG-ovum pickup(OPU)	1	1
Overall Study Withdrawal between OPU - embryo transfer	3	2

Baseline Characteristics

A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.	Total n=75 Participants Total of all reporting groups
Age, Continuous	37.2 years STANDARD_DEVIATION 2.2 • n=5 Participants	37.3 years STANDARD_DEVIATION 1.5 • n=7 Participants	37.2 years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	35 Participants n=7 Participants	75 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: Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])

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

Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Implantation Rate	0.2 sacs per embryo Standard Deviation 0.4	0.2 sacs per embryo Standard Deviation 0.3

SECONDARY outcome

Timeframe: r-hCG day (end of stimulation cycle [approximately 28 days])

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

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day	7.7 follicles Standard Deviation 4.9	8.7 follicles Standard Deviation 4.0

SECONDARY outcome

Timeframe: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])

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

Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) was calculated. 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

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Mean Number of Oocytes Retrieved	5.9 oocytes Standard Deviation 3.9	7.7 oocytes Standard Deviation 4.0

SECONDARY outcome

Timeframe: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])

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

Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) was calculated. 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. The nuclear maturity was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number of Mature Oocytes Retrieved	234 mature oocytes	271 mature oocytes

SECONDARY outcome

Timeframe: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])

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

Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number of Fertilized Oocytes (2 Pronuclei [PN])	128 2PN oocytes	136 2PN oocytes

SECONDARY outcome

Timeframe: Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. Here "N" represents the number of participants who had at least one fertilized oocyte.

Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=31 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=32 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number and Quality of Embryos A + B (good quality)	69 embyros	65 embyros
Number and Quality of Embryos C + D (poor quality)	56 embyros	73 embyros
Number and Quality of Embryos Total embryos	125 embyros	138 embyros

SECONDARY outcome

Timeframe: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])

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

Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number of Participants With Biochemical Pregnancies	11 participants	10 participants

SECONDARY outcome

Timeframe: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 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 includes ectopic pregnancy.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number of Participants With Clinical Pregnancies	10 participants	10 participants

SECONDARY outcome

Timeframe: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])

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

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)	2812.2 IU Standard Deviation 719.4	2970.3 IU Standard Deviation 748.2

SECONDARY outcome

Timeframe: r-hCG day (end of stimulation cycle [approximately 28 days])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. Here "N" represents the number of participants with plasma E2 levels at r-hCG day.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=33 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=29 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Estradiol (E2) Levels on r-hCG Day	1890.2 picogram/milliter (pg/mL) Standard Deviation 1084.4	1621 picogram/milliter (pg/mL) Standard Deviation 827.8

SECONDARY outcome

Timeframe: S1 up to r-hCG day (end of stimulation cycle [approximately 28 days])

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

Ovarian stimulation included from first rFSH injection (S1) until day on which r-hCG was administered (r-hCG day). This period was divided into 2 parts: the first period in which 300 International Unit (IU) rFSH dose was constant and which covered from S1 to Day 4 of stimulation period (S4); the second period in which the rFSH dose could be adjusted depending on the ovarian response and which began on S4 and finished on the day on which the criteria for administration of r-hCG to induce the final follicular maturation were met.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number of Ovarian Stimulation Days	9.7 Days Standard Deviation 2.1	9.8 Days Standard Deviation 1.9

SECONDARY outcome

Timeframe: Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])

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

Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response	4 cycles	1 cycles

SECONDARY outcome

Timeframe: Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])

Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. Here "N" represents number of participants evaluated for this measure.

Total number of births per reporting group was calculated.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=34 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Total Number of Births	10 births	9 births

SECONDARY outcome

Timeframe: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])

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

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number of Participants With Adverse Events (AEs)	19 participants	9 participants

SECONDARY outcome

Timeframe: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])

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

OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])

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

OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.

Outcome measures

Outcome measures
Measure	rFSH + rhLH n=40 Participants Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 Participants Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)	1 cycles	0 cycles

Adverse Events

rFSH + rhLH

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

rFSH

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	rFSH + rhLH n=40 participants at risk Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.	rFSH n=35 participants at risk Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
Musculoskeletal and connective tissue disorders New born hip dysplasia	2.5% 1/40 • 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 35-42 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 35- 42 for participants who completed the study.	0.00% 0/35 • 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 35-42 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 35- 42 for participants who completed the study.
Skin and subcutaneous tissue disorders Cutaneous anginoma	2.5% 1/40 • 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 35-42 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 35- 42 for participants who completed the study.	0.00% 0/35 • 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 35-42 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 35- 42 for participants who completed the study.
Congenital, familial and genetic disorders Trisomy 13	0.00% 0/40 • 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 35-42 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 35- 42 for participants who completed the study.	2.9% 1/35 • 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 35-42 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 35- 42 for participants who completed the study.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee
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