MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagon... | NCT00884221

ID	Type	Description	Link
EudraCT Number: 2008-006775-67

Label	Type	Description	Intervention Names
Highly Purified Menotrophin	Experimental		Drug: Highly purified menotrophin
Recombinant FSH	Active Comparator		Drug: Recombinant FSH

Name	Type	Description	Arm Group Labels	Other Names
Highly purified menotrophin	Drug	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days. NOTE: The gonadotrophins (highly purified menotrophin and the active comparator recombinant FSH) were administered in an identical fashion.

Measure	Description	Time Frame
Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set	Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage	10-11 weeks after embryo transfer at the blastocyst stage
Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set	Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage	10-11 weeks after embryo transfer at the blastocyst stage

Measure	Description	Time Frame
Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set	Blood samples for analysis of circulating concentrations of endocrine parameters were drawn	On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist
Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
ERASME Hospital		Anderlecht			Belgium
UZ Brussel

PubMed Identifier	Type	Citation	Retractions
22244781	Result	Devroey P, Pellicer A, Nyboe Andersen A, Arce JC; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer Trial Group. A randomized assessor-blind trial comparing highly purified hMG and recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer. Fertil Steril. 2012 Mar;97(3):561-71. doi: 10.1016/j.fertnstert.2011.12.016. Epub 2012 Jan 13.
23394782

ID	Title	Description
FG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.

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

Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set

Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

Percentage of participants

10-11 weeks after embryo transfer at the blastocyst stage

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Units	Counts
Participants	OG000374 OG001375

Title

Denominators

Categories

Title	Measurements
	OG00029± 2.3(-4.2 to 8.6) OG00127± 2.3

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	The non-inferiority hypothesis to be tested for the primary endpoint was: H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH > -10.0%, where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol.	Sign test	A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.	0.499	Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.	Difference in pregnancy rates, ITT	2.2			2-Sided	95	-4.2	8.6

Secondary

Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

pmol/L

On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

IU/L

On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn. Free androgen index = (testosterone (nmol/L)/ sex hormone binding globulin (nmol/L))*100

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

Percentage of participants

On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

IU/L

On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

nmol/L

On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Primary

Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set

Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage

The per-protocol (PP) analysis set was defined as all randomized and exposed participants except those excluded as a result of major protocol deviations, such as significant non-compliance or other serious unforeseen deviations deemed to invalidate the data and affect the conclusions of the trial.

Posted

Mean

Standard Deviation

Percentage of participants

10-11 weeks after embryo transfer at the blastocyst stage

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

pmol/L

On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

nmol/L

On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set

Blood samples for analysis of circulating concentrations of endocrine parameters were drawn

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

nmol/L

On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Number of Follicles of >= 12mm, 12-14 mm, 15-16 mm and >= 17 mm in Each Participant, Intention-to-treat (ITT) Analysis Set

During the controlled ovarian stimulation, transvaginal ultrasound was performed to count the number of follicles and measure the size of the follicles.

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

Follicles per participant

Last stimulation day

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Number of Oocytes Retrieved in Each Participant, Intention-to-treat (ITT) Analysis Set

Oocyte retrieval took place 36h (± 2h) after hCG administration. At oocyte retrieval, the number of oocytes retrieved was recorded.

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

Oocytes per participant

36 h after hCG

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Fertilization, Intention-to-treat (ITT) Analysis Set

Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized. Fertilization was estimated as (Number of oocytes with 2 pronuclei / number of metaphase II oocytes)*100

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

Percentage of metaphase II oocytes

1 day after oocyte retrieval (19 h post-insemination)

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Blastocyst Quality, Intention-to-treat (ITT) Analysis Set

Blastocyst quality on day 5 was based on the blastocyst expansion and hatching status, inner cell mass grading and trophectoderm grading.

Excellent-quality blastocysts were defined as those with blastocyst expansion and hatching status 4, 5 or 6, inner cell mass grading A, and trophectoderm grading A or B. Good-quality blastocysts were defined as those with blastocyst expansion and hatching status 3, 4, 5 or 6, inner cell mass grading A or B, and trophectoderm grading A or B.

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

Number of blastocysts

5 days after oocyte retrieval (120h post-insemination)

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

Percentage of participants

Post-trial information

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.

Secondary

Cumulative Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh and 1 Year Frozen Embryo Replacement Cycles, Intention-to-treat (ITT) Analysis Set

The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.

Posted

Mean

Standard Deviation

Percentage of participants

Post-trial information

ID	Title	Description
OG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
OG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected374 at risk EG0010 events0 affected375 at risk
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected374 at risk EG0012 events2 affected375 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected374 at risk EG0011 events1 affected375 at risk
Abortion threatened	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected374 at risk EG0011 events1 affected375 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected374 at risk EG0011 events1 affected375 at risk
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected374 at risk EG0012 events2 affected375 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected374 at risk EG0010 events0 affected375 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG00019 events18 affected374 at risk EG00116 events15 affected375 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG00030 events25 affected374 at risk EG00123 events19 affected375 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment		EG00027 events27 affected374 at risk EG00119 events19 affected375 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment		EG00023 events18 affected374 at risk EG00120 events16 affected375 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	Episodes of vaginal haemorrhage mainly covered episodes of vaginal bleeding during pregnancy not associated with pregnancy loss; no episodes during ovarian stimulation with highly purified menotrophin or recombinant FSH.	EG00025 events21 affected374 at risk EG00113 events10 affected375 at risk

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D008596	Menotropins
D015292	Glycoprotein Hormones, alpha Subunit
C571802	follitropin beta

ID	Term
D006065	Gonadotropins, Pituitary
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D001688	Biological Products
D045424	Complex Mixtures
D006063	Chorionic Gonadotropin
D005640	Follicle Stimulating Hormone
D007986	Luteinizing Hormone
D013972	Thyrotropin
D010926	Placental Hormones

ID	Title	Description
BG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
BG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Highly Purified Menotrophin	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.			5	374	66	374
EG001	Recombinant FSH	The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.			7	375	47	375