Analysis of Two Therapeutic With Cetrotide® in Polycystic... | NCT01185704

NCT01185704

ID	Type	Description	Link
2007-007932-25	EudraCT Number
INI 28091	Other Identifier	Merck KGaA

Status Module

Sponsor/Collaborators Module

Name	Class
Merck Serono S.A.S, France	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Day 1 protocol	Experimental		Drug: Cetrorelix acetate Drug: Recombinant Human Choriogonadotropin (r-hCG) Drug: Recombinant human follicle stimulating hormone (r-hFSH)
Day 7 protocol	Experimental		Drug: Cetrorelix acetate Drug: Recombinant Human Choriogonadotropin (r-hCG) Drug: Recombinant human follicle stimulating hormone (r-hFSH)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetrorelix acetate	Drug	Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) until r-hCG day (at least 2 follicles >=17 mm)

Outcomes Module

Measure	Description	Time Frame
Estradiol (E2) Levels on r-hCG Day		r-hCG day (end of stimulation cycle [approximately 15 days])

Measure	Description	Time Frame
Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels		Day 1
Serum Estradiol (E2) Levels		Day 1
Serum Progesterone (P4) Levels

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised 2003 Rotterdam Consensus
Female subjects suitable for IVF/ICSI, undergoing first or second attempt
18-35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least from Visit 0 (V0)
Normal FSH value (less than 10 international unit per liter [IU/L]) on Day 3 of spontaneous cycle within 12 months prior to the trial
Anti Mullerian Hormone (AMH) value (greater than 1.5 nanogram per milliliter [ng/mL]) of a spontaneous cycle within 12 months prior to the trial or at least at V0
No history of active genito-urinary infection
Normal thyroid function (or adequate substitution for at least 3 months)
Negative cervical papanicolaou test within the last 12 months prior to study entry
No gonadotropins, for at least one month prior to the trial
No metformin therapy for at least one month prior to Visit 1 (V1)
Subject who is able to participate in the trial and has provided written, informed consent.

Exclusion Criteria:

Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term
Drilling 3 months prior to V0
Uterine malformation, diethylstilbestrol syndrome, synechia
Female subjects with World Health Organization (WHO) Type I or III anovulation
Female subjects with hyperprolactinemia
Female subjects with more than 2 recurrent miscarriages (early or late, and for any reasons)
Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for subject or partner
Abnormal gynecological bleeding of undetermined origin
History of major thromboembolic disease
Endometriosis (Grade III or IV)
Presence or history of malignant tumors and related treatment
Known case of tumors of the hypothalamus or pituitary gland
Clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening
Known allergic reaction or hypersensitivity to Cetrotide® or Ovitrelle®
Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years
Participation in another clinical trial within 3 months prior to study entry.

Contacts/Locations Module

Name	Affiliation	Role
Dr Etienne VARLAN	Merck Lipha Santé	Study Director

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00065 BG00165 BG002130

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0001668.86± 862.62 OG0011672.80± 835.49

Secondary

Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels

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.

Posted

Mean

Standard Deviation

International unit/liter (IU/L)

Day 1

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Serum Estradiol (E2) Levels

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.

Posted

Mean

Standard Deviation

pg/mL

Day 1

ID	Title	Description
OG000	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.
OG001	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.

Units

Secondary

Serum Progesterone (P4) Levels

Posted

Mean

Standard Deviation

nanomolar/liter (nmol/L)

Day 1

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Anti Mullerian Hormone (AMH) Levels

Posted

Mean

Standard Deviation

nanogram/milliliter (ng/mL)

Day 0

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

Posted

Mean

Standard Deviation

follicles

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number and Quality of Oocytes Retrieved

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.

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

Posted

Mean

Standard Deviation

oocytes

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)

Posted

Mean

Standard Deviation

international unit (IU)

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Fertilized Oocytes Retrieved

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.

Posted

Mean

Standard Deviation

percent fertilized oocytes

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Embryos

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

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

Posted

Mean

Standard Deviation

embryos

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Blastocysts

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.

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

Posted

Mean

Standard Deviation

blastocysts

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Transferred Embryos

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

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

Posted

Mean

Standard Deviation

transferred embryos

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Implantation Rate

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

Posted

Number

percent sacs per embryo

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants With Clinical Pregnancy

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.

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

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Posted

Number

participants

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

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			2	65	9	65
EG001	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.			4	65	14	65

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (Unspecified)	Non-systematic Assessment		EG0000 affected65 at risk EG0011 affected65 at risk
Ovarian Hyperstimulation syndrome	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment		EG0002 affected65 at risk EG0013 affected65 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected65 at risk EG0011 affected65 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected65 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected65 at risk EG0011 affected65 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 affected65 at risk EG0011 affected65 at risk
Injection site erythema	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected65 at risk EG0011 affected65 at risk
Injection site irritation	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected65 at risk
Injection site burning	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected65 at risk
Injection site pruritus	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected65 at risk EG0011 affected65 at risk
Pyrexia	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected65 at risk
Ovarian Hyperstimulation syndrome	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected65 at risk EG0016 affected65 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 affected65 at risk EG0013 affected65 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected65 at risk EG0011 affected65 at risk
Adnexa uterin pain	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected65 at risk
Oestradiol increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected65 at risk
Hot flush	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected65 at risk
Injection site pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected65 at risk EG0011 affected65 at risk

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

ID	Term
C062876	cetrorelix
D006063	Chorionic Gonadotropin
D015292	Glycoprotein Hormones, alpha Subunit

Ancestor Terms

ID	Term
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010926	Placental Hormones
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011257	Pregnancy Proteins
D011506	Proteins
D005640	Follicle Stimulating Hormone
D006065	Gonadotropins, Pituitary
D007986	Luteinizing Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D013972	Thyrotropin

Units	Counts
Participants	OG00058 OG00162

Units	Counts
Participants	OG00058 OG00161

Units	Counts
Participants	OG00064 OG00165

Units	Counts
Participants	OG00065 OG00165

Units	Counts
Participants	OG00065 OG00165