Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00702546
• Collaborator: (none)
• Enrollment: 102
• Duration (Months): 24

Study Details

Study Description

Brief Summary

Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.

Condition or Disease	Intervention/Treatment	Phase
In Vitro Fertilization	Drug: corifollitropin alfa; Biological: recFSH (follitropin alfa); Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Drug: human chorion gonadatropin (hCG); Biological: progesterone; Drug: placebo-recFSH (follitropin alfa); Drug: placebo-corifollitropin alfa; Biological: open-label recFSH

Detailed Description

This is a follow-up protocol to collect the outcome of FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the cumulative pregnancy rate for each treatment group.

Study Design

• Study Type: Observational
• Actual Enrollment: 102 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Corifollitropin alfa 100 μg In follow-up study, no medication or investigational product was administered. But in base study P05690 (NCT00702845), participants received 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 in base study P05690 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 IM), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.	Drug: corifollitropin alfa; Single injection of 100 μg corifollitropin alfa administered under protocol P05690; Other Names: Org 36286 ; Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690; Drug: human chorion gonadatropin (hCG); hCG 5,000 IU or 10,000 IU administered SC under protocol P05690; Biological: progesterone; Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.; Drug: placebo-recFSH (follitropin alfa); Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690; Biological: open-label recFSH; Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590
recFSH 150 IU In this follow-up study, no medication or investigational product was administered. However, in base study P05690 (NCT00702845), 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.	Biological: recFSH (follitropin alfa); Daily recFSH administered under protocol P05690; Other Names: Puregon®/Follistim® ; Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690; Drug: human chorion gonadatropin (hCG); hCG 5,000 IU or 10,000 IU administered SC under protocol P05690; Biological: progesterone; Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.; Drug: placebo-corifollitropin alfa; Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690; Biological: open-label recFSH; Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) [Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711]

   Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.

Secondary Outcome Measures

1. Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy [After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)]

   Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.

2. Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy [After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)]

   Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.

3. Percentage of Participants in Follow up Study With an Ecotopic Pregnancy [After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)]

   An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.

4. Percentage of Participants in Follow up Study With a Clinical Pregnancy [After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)]

   A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.

5. Percentage of Participants in Follow up Study With a Vital Pregnancy [After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)]

   A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.

6. Percentage of Participants With an Ongoing Pregnancy [After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)]

   An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 36 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants from whom embryos have been cryopreserved in base study P05690, of which at least one embryo is thawed for use in a subsequent FTET cycle;

• Able and willing to give written informed consent.

Exclusion Criteria:

• None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00702546
• Other Study ID Numbers: P05711; 2006-003813-42; 107015; MK-8962-004
• First Posted: Jun 20, 2008
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Organon and Co: In-vitro fertilization; Controlled Ovarian Stimulation; Cumulative pregnancy data; Follow-up
• Additional relevant MeSH terms: Hormones; Progesterone; Follicle Stimulating Hormone; Ganirelix

Study Results

Participant Flow

Pre-assignment Detail	Period one consists of participants from the base study P05690 (NCT00702845) randomized to treatment groups corifollitropin alfa (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of eligible participants (N = 102) from the base study who enrolled in the follow up study P05711.

Arm/Group Title	Corifollitropin Alfa 100 μg	recFSH 150 IU
Arm/Group Description	Participants in base study P05690 received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of 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 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Period Title: Base Study P05690 (NCT00702845)
STARTED	268	128
COMPLETED	246	121
NOT COMPLETED	22	7
Period Title: Base Study P05690 (NCT00702845)
STARTED	77	25
COMPLETED	72	24
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	Corifollitropin Alfa 100 μg	recFSH 150 IU	Total
Arm/Group Description	Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.	Total of all reporting groups
Overall Participants	77	25	102
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	31.2 (3.0)	31.2 (2.8)	31.2 (2.9)
Sex: Female, Male (Count of Participants)
Female	77 100%	25 100%	102 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
Description	Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.
Time Frame	Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.

Arm/Group Title	Corifollitropin Alfa 100 μg	recFSH 150 IU
Arm/Group Description	Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Measure Participants	268	128
Number [Percentage of participants]	32.1 41.7%	41.4 165.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Corifollitropin Alfa 100 μg, recFSH 150 IU
	Comments	Treatment groups were compared with a generalized linear model for the cumulative ongoing pregnancy rate including covariates treatment group, age class (< 32 yrs vs. ≥ 32 yrs), planned IVF treatment (IVF vs. ICSI) and region (Europe vs. Asia).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-9.4
	Confidence Interval	(2-Sided) 95%; -19.5 to 0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy
Description	Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.
Time Frame	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

Outcome Measure Data

Analysis Population Description

Participants in follow up study P05711 with a clinical pregnancy

Arm/Group Title	Corifollitropin Alfa 100 μg	recFSH 150 IU
Arm/Group Description	Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Measure Participants	22	10
Number [Percentage of participants]	13.6 17.7%	10.0 40%

3. Secondary Outcome

Title	Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy
Description	Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.
Time Frame	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

Outcome Measure Data

Analysis Population Description

Participants enrolled in follow up study P05711 with vital pregnancy

Arm/Group Title	Corifollitropin Alfa 100 μg	recFSH 150 IU
Arm/Group Description	Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Measure Participants	19	9
Number [Percentage of participants]	0.0 0%	0.0 0%

4. Secondary Outcome

Title	Percentage of Participants in Follow up Study With an Ecotopic Pregnancy
Description	An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.
Time Frame	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

Outcome Measure Data

Analysis Population Description

Participants enrolled in follow up study P05711

Arm/Group Title	Corifollitropin Alfa 100 μg	recFSH 150 IU
Arm/Group Description	Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Measure Participants	77	25
Number [Percentage of participants]	1.3 1.7%	0.0 0%

5. Secondary Outcome

Title	Percentage of Participants in Follow up Study With a Clinical Pregnancy
Description	A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.
Time Frame	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

Outcome Measure Data

Analysis Population Description

Participants enrolled in follow up study P05711

Arm/Group Title	Corifollitropin Alfa 100 μg	recFSH 150 IU
Arm/Group Description	Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Measure Participants	77	25
Number [Percentage of participants]	28.6 37.1%	40.0 160%

6. Secondary Outcome

Title	Percentage of Participants in Follow up Study With a Vital Pregnancy
Description	A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.
Time Frame	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)

Outcome Measure Data

Analysis Population Description

Participants enrolled in follow up study P05711

Arm/Group Title	Corifollitropin Alfa 100 μg	recFSH 150 IU
Arm/Group Description	Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Measure Participants	77	25
Number [Percentage of participants]	24.7 32.1%	36.0 144%

7. Secondary Outcome

Title	Percentage of Participants With an Ongoing Pregnancy
Description	An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.
Time Frame	After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)

Outcome Measure Data

Analysis Population Description

Participants enrolled in follow up study P05711

Arm/Group Title	Corifollitropin Alfa 100 μg	recFSH 150 IU
Arm/Group Description	Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
Measure Participants	77	25
Number [Percentage of participants]	23.4 30.4%	36.0 144%

Adverse Events

Adverse Event Reporting Description	In Follow Up Study P05711, Serious Adverse Events (AEs) were not systematically monitored. Instead, any reported Serious AEs were unsolicited and non-systematically assessed. Other Adverse Events were not monitored and not collected.
Arm/Group Title	Corifollitropin Alfa 100 μg		recFSH 150 IU
Arm/Group Description	Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants 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 Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.		Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
All Cause Mortality
	Corifollitropin Alfa 100 μg		recFSH 150 IU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Corifollitropin Alfa 100 μg		recFSH 150 IU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/77 (1.3%)		0/25 (0%)
Congenital, familial and genetic disorders
Cytogenetic abnormality	1/77 (1.3%)	1	0/25 (0%)	0
Other (Not Including Serious) Adverse Events
	Corifollitropin Alfa 100 μg		recFSH 150 IU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.