Trial Outcomes & Findings for A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies (NCT NCT01121991)

NCT ID: NCT01121991

Last Updated: 2013-08-07

Results Overview

Mean number of metaphase II oocytes was calculated for each participant undergoing ovum pick up for ICSI. ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

55 participants

Primary outcome timeframe

On the day of ovum pick up (Day 1 or 2 after human chorionic gonadotropin [hCG] administration).

Results posted on

2013-08-07

Participant Flow

Participants were recruited in 4 study centers in Canada from September 2004 to October 2005.

55 participants were enrolled in the study, 3 participants discontinued prior to study drug administration as they did not meet the eligibility criteria.

Participant milestones

Participant milestones
Measure	Recombinant Human-Luteinizing Hormone (Luveris) All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Overall Study STARTED	52
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Recombinant Human-Luteinizing Hormone (Luveris) All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Overall Study Lack of Ovarian Response	2
Overall Study No Oocytes Retrieved	3
Overall Study No Fertilization	1

Baseline Characteristics

A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=52 Participants All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Age Continuous	34.6 years STANDARD_DEVIATION 3.6 • n=5 Participants
Age, Customized <35 years	22 participants n=5 Participants
Age, Customized >=35 years	30 participants n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants
Race/Ethnicity, Customized White	47 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants
Race/Ethnicity, Customized Aboriginal	1 participants n=5 Participants
Region of Enrollment Canada	52 participants n=5 Participants
Smoking 0 cigarettes per day	50 participants n=5 Participants
Smoking 6-20 cigarettes per day	1 participants n=5 Participants
Smoking >20 cigarettes per day	1 participants n=5 Participants

PRIMARY outcome

Timeframe: On the day of ovum pick up (Day 1 or 2 after human chorionic gonadotropin [hCG] administration).

Population: Analysis population includes those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope.

Outcome measures

Outcome measures
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=22 Participants All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Mean Number of Metaphase II Oocytes Per Participant Who Underwent Ovum Pick up for Intra-cytoplasmic Sperm Injection (ICSI)	9.5 Metaphase II Oocytes Standard Deviation 4.2

PRIMARY outcome

Timeframe: On the day of ovum pick up (Day 1 or 2 after hCG administration).

Population: Analysis population includes those participants undergoing IVF whose oocytes were assessed for maturity. Mature oocytes can be considered as Metaphase II oocytes.

Mean number of oocytes undergoing ovum pick up for IVF were calculated for each participant. IVF is a process by which egg cells are fertilized by sperm outside the body, in-vitro.

Outcome measures

Outcome measures
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=4 Participants All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Mean Number of Mature Oocytes Per Participant Who Underwent Ovum Pick up for In Vitro Fertilization (IVF)	7.5 oocytes Standard Deviation 6.8

SECONDARY outcome

Timeframe: On day of ovum pick up (Day 1 or 2 after hCG administration)

Population: ITT population: all participants who received at least one dose of the study drug and underwent vaginal ovum pick up.

Mean number of oocytes retrieved per number of follicles aspirated on the day of ovum pick up 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	Recombinant Human-Luteinizing Hormone (Luveris) n=50 Participants All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Mean Number of Oocytes Retrieved Per Number of Follicles Aspirated on the Day of Ovum Pick up	0.9 oocytes per aspirated follicle Standard Deviation 0.2

SECONDARY outcome

Timeframe: Post-hCG days 15-20 and post-hCG days 35-42.

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

Biochemical pregnancy: A positive pregnancy test defined as hCG level \>10 IU/L in a sample taken at least 14 days after Day 3 embryo transfer or 12 days after Day 5/6 embryo transfer with no further ultrasound confirmation of the existence of a gestational sac in the uterus. Clinical pregnancy: Existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.

Outcome measures

Outcome measures
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=52 Participants All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies Participants with confirmed biochemical pregnancy	22 participants
Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies Participants with confirmed clinical pregnancy	14 participants

SECONDARY outcome

Timeframe: Post-hCG Day 35-42.

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

Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning-identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.

Outcome measures

Outcome measures
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=52 Participants All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Number of Participants With Multiple Pregnancies	4 participants

SECONDARY outcome

Timeframe: Post-hCG days 15-20 to pregnancy follow up.

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

A live birth occurs when a fetus, whatever its gestational age, exits the maternal body and subsequently shows any sign of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord, for however brief a time and regardless of whether the umbilical cord or placenta are intact.

Outcome measures

Outcome measures
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=52 Participants All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Number of Live Births	13 Live births

SECONDARY outcome

Timeframe: Post-hCG days 35-42.

Population: Participants with confirmed clinical pregnancies.

Preclinical miscarriage: Spontaneous cessation of a biochemical pregnancy. Early spontaneous abortion: Any spontaneous abortion occurring after confirmation of clinical pregnancy and before completion of 12 weeks of gestation. Late spontaneous abortion: any spontaneous abortion occurring between completion of 12 weeks of gestation and prior to a viable stage. Pregnancy loss per clinical pregnancy was measured as a percentage.

Outcome measures

Outcome measures
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=14 Participants All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Pregnancy Loss Per Clinical Pregnancy	7.14 Percentage of pregnancy loss

SECONDARY outcome

Timeframe: From stimulation Day 1 (S1) to post-hCG days 35-42 (safety visit).

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

AEs: Any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. TEAEs: AEs that occur during treatment with the study drug. It also included incidences of mild, moderate and severe ovarian hyperstimulation syndrome (OHSS). SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded.

Outcome measures

Outcome measures
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=52 Participants All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation. TEAEs	15 Number of participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation. SAEs	3 Number of participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation. Discontinuation due to AEs	0 Number of participants

Adverse Events

Recombinant Human-Luteinizing Hormone (Luveris)

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=52 participants at risk All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
Gastrointestinal disorders Abdominal pain	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Reproductive system and breast disorders Metrorrhagia	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Injury, poisoning and procedural complications Post procedural hemorrhage	1.9% 1/52 • 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 15- 42 for participants who completed the study.

Other adverse events

Other adverse events
Measure	Recombinant Human-Luteinizing Hormone (Luveris) n=52 participants at risk All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
General disorders Local tolerability of injections	9.6% 5/52 • 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 15- 42 for participants who completed the study.
Gastrointestinal disorders Abdominal distension	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Gastrointestinal disorders Constipation	3.8% 2/52 • 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 15- 42 for participants who completed the study.
Gastrointestinal disorders Diarrhea	3.8% 2/52 • 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 15- 42 for participants who completed the study.
Gastrointestinal disorders Flatulence	1.9% 1/52 • 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 15- 42 for participants who completed the study.
General disorders Fatigue	3.8% 2/52 • 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 15- 42 for participants who completed the study.
General disorders Injection site pain	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Infections and infestations Vulvovaginal mycotic infection	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Injury, poisoning and procedural complications Post procedural nausea	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Injury, poisoning and procedural complications Procedural pain	3.8% 2/52 • 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 15- 42 for participants who completed the study.
Injury, poisoning and procedural complications Procedural vomiting	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Nervous system disorders Headache	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Nervous system disorders Loss of consciousness	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Pregnancy, puerperium and perinatal conditions Intra-uterine death	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Psychiatric disorders Anxiety	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Renal and urinary disorders Dysuria	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Reproductive system and breast disorders Genital pruritus female	1.9% 1/52 • 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 15- 42 for participants who completed the study.
Reproductive system and breast disorders Ovarian Hyperstimulation Syndrome	5.8% 3/52 • 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 15- 42 for participants who completed the study.
Skin and subcutaneous tissue disorders Ecchymosis	1.9% 1/52 • 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 15- 42 for participants who completed the study.

Additional Information

Medical Responsible

EMD Serono Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +1-888-737-6668

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER