To Investigate Efficacy and Safety of a Single Injection... | NCT00702845

NCT00702845

ID	Type	Description	Link
2006-003811-36	EudraCT Number
107012	Other Identifier	Organon Study Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
corifollitropin alfa 100 µg	Experimental	Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.	Drug: corifollitropin alfa (Org 36286) Drug: gonadatropin releasing hormone (GnRH) antagonist (ganirelix) Drug: human chorion gonadatropin (hCG) Biological: progesterone Drug: placebo-recFSH (follitropin alfa) Biological: open-label recFSH
recFSH 150 IU	Active Comparator	Participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.	Drug: recFSH (follitropin beta) Drug: gonadatropin releasing hormone (GnRH) antagonist (ganirelix)

Name	Type	Description	Arm Group Labels	Other Names
corifollitropin alfa (Org 36286)	Drug	100 µg corifollitropin alfa subcutaneous (SC) injection	corifollitropin alfa 100 µg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Cumulus-oocyte-complexes Retrieved, Per Attempt	The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.	One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)

Secondary Outcomes

Measure	Description	Time Frame
Total Dose of recFSH Administered	Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm).	One COS cycle (up to a maximum total duration of 19 stimulation days)
Total Dose of recFSH Administered From Day 8 Onwards

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females of couples with an indication for COS and IVF or ICSI;
>=18 and <= 36 years of age at the time of signing informed consent;
Body weight <= 60 kg and BMI >= 18 and <= 32 kg/m^2;
Normal menstrual cycle length: 24-35 days;
Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
Willing and able to sign informed consent.

Exclusion Criteria:

History of/or any current (treated) endocrine abnormality;
History of ovarian hyper-response or ovarian hyperstimulation syndrome

(OHSS);

History of/or current polycystic ovary syndrome (PCOS);
More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);
Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm; visible on USS);
Presence of unilateral or bilateral hydrosalphinx (visible on USS);
Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >= 5 cm;
More than three unsuccessful IVF cycles since the last established ongoing

pregnancy (if applicable);

History of non- or low ovarian response to FSH/hMG treatment;
History of recurrent miscarriage (3 or more, even when unexplained);
FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular,

gastro-intestinal, hepatic, renal or pulmonary disease;

Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
Smoking more than 5 cigarettes per day;
History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
Previous use of Org 36286;
Use of hormonal preparations within 1 month prior to randomization;
Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
Administration of investigational drugs within three months prior to signing informed consent.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20483664	Result	Corifollitropin alfa Ensure Study Group. Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women. Reprod Biomed Online. 2010 Jul;21(1):66-76. doi: 10.1016/j.rbmo.2010.03.019. Epub 2010 Mar 28.
26991902	Derived	Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	100 μg Corifollitropin Alfa	Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
BG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000268 BG001128 BG002396

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Cumulus-oocyte-complexes Retrieved, Per Attempt

The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.

Intent-to-Treat (ITT) Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.

Posted

Mean

Standard Deviation

Number of cumulus-oocyte-complexes

One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Units	Counts
Participants	OG000268 OG001128

Title

Denominators

Categories

Title	Measurements
	OG00013.3± 7.3 OG00110.6± 5.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA		<0.001		Mean Difference (Final Values)	2.5			2-Sided	95	1.2	3.9					Non-Inferiority or Equivalence (legacy)	Equivalence margins of -3 and +5 were applied for the difference in the mean number of oocytes between the treatment groups. Org 36286 treatment was considered equivalent to the reference treatment (recFSH) if the two-sided 95% confidence interval of the difference was between -3 and +5 oocytes.

Secondary

Total Dose of recFSH Administered

Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm).

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Median

Full Range

International Unit (IU)

One COS cycle (up to a maximum total duration of 19 stimulation days)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Total Dose of recFSH Administered From Day 8 Onwards

Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles >=17mm).

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Median

Full Range

International Unit (IU)

Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Number of Days Treated With recFSH

Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles >=17mm).

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Median

Full Range

Days

One COS cycle (up to a maximum total duration of 19 stimulation days)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Total Duration of Stimulation (Days)

Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Median

Full Range

Days

One COS cycle (up to a maximum total duration of 19 stimulation days)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Median

Full Range

IU/L

Predose up to 2 weeks after ET (up to maximum of 6 weeks)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Median

Full Range

IU/L

Predose up to 2 weeks after ET (up to maximum of 6 weeks)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Median

Full Range

pmol/L

Predose up to 2 weeks after ET (up to maximum of 6 weeks)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Median

Full Range

nmol/L

Predose up to 2 weeks after ET (up to maximum of 6 weeks)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)

Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Median

Full Range

pg/mL

Predose up to 2 weeks after ET (up to maximum of 6 weeks)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration

For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.

Posted

Mean

Standard Deviation

Follicles

Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)

The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes).

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ICSI.

Posted

Mean

Standard Deviation

Number of oocytes

Up to 36 hours after administration of hCG

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Fertilization Rate

Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received fertilized oocytes.

Posted

Mean

Standard Deviation

Percentage

Up to 10 weeks after ET

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)

Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. "Other" grade embryos were those that did not qualify as Grade 1, 2, or 3.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent IVF and/or ICSI.

Posted

Mean

Standard Deviation

Number of embryos

Post fertilization Day 3 (up to a maximum of 2 days after hCG administration)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Implantation Rate for Participants With ET

The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ET.

Posted

Mean

Standard Deviation

Percentage

Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Number of Participants With Miscarriages

A miscarriage, also known as a "spontaneous abortion," was defined as the loss of a fetus without induction or instrumentation.

Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who had a biological pregnancy.

Posted

Number

Participants

Up to 10 weeks after ET (up to a maximum of 14 weeks)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
OG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Secondary

Number of Participants With Pregnancies

A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth.

ITT Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.

Posted

Number

Participants

Up to 10 weeks after ET (up to a maximum of 14 weeks)

ID	Title	Description
OG000	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.

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	100 μg Corifollitropin Alfa	Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.			20	268	107	268
EG001	150 IU recFSH	Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.			9	129	55	129

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected268 at risk EG0011 events1 affected129 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected268 at risk EG0010 events0 affected129 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected268 at risk EG0010 events0 affected129 at risk
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected268 at risk EG0010 events0 affected129 at risk
Abortion threatened	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected268 at risk EG0010 events0 affected129 at risk
Antepartum haemorrhage	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected268 at risk EG0011 events1 affected129 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG0008 events8 affected268 at risk EG0012 events2 affected129 at risk
Heterotopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected268 at risk EG0011 events1 affected129 at risk
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected268 at risk EG0011 events1 affected129 at risk
Imminent abortion	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected268 at risk EG0011 events1 affected129 at risk
Ruptured ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected268 at risk EG0011 events1 affected129 at risk
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0007 events7 affected268 at risk EG0010 events0 affected129 at risk
Ovarian torsion	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected268 at risk EG0010 events0 affected129 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected268 at risk EG0011 events1 affected129 at risk
Abortion induced	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected268 at risk EG0011 events1 affected129 at risk
Selective abortion	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected268 at risk EG0010 events0 affected129 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00013 events13 affected268 at risk EG0017 events7 affected129 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00030 events25 affected268 at risk EG00117 events12 affected129 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG00014 events14 affected268 at risk EG0018 events8 affected129 at risk
Antepartum haemorrhage	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG00022 events18 affected268 at risk EG00117 events17 affected129 at risk
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG00015 events14 affected268 at risk EG0017 events6 affected129 at risk
Pelvic discomfort	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG00042 events27 affected268 at risk EG00124 events19 affected129 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG00030 events29 affected268 at risk EG00117 events14 affected129 at risk

Ancestor Terms

ID	Term
D006063	Chorionic Gonadotropin
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D005640	Follicle Stimulating Hormone
D006065	Gonadotropins, Pituitary
D007986	Luteinizing Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D013972	Thyrotropin
D010926	Placental Hormones
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D009479	Neuropeptides
D009842	Oligopeptides
D009419	Nerve Tissue Proteins
D011506	Proteins
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D003339	Corpus Luteum Hormones
D042341	Gonadal Hormones
D045167	Progesterone Congeners
D012739	Gonadal Steroid Hormones

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
C437186	follicle stimulating hormone, human, with HCG C-terminal peptide
C571802	follitropin beta
D015292	Glycoprotein Hormones, alpha Subunit
D007987	Gonadotropin-Releasing Hormone
C061018	ganirelix
D011374	Progesterone
C571801	follitropin alfa