Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)

NCT ID: NCT00702624

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 113 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-06-30

Brief Summary

The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring.

Detailed Description

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.

Conditions

Pregnancy; Neonates

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Corifollitropin alfa 100 μg

In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants 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 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 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.

Corifollitropin alfa

Intervention Type: DRUG

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

gonadatropin releasing hormone (GnRH) antagonist ganirelix

Intervention Type: DRUG

GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690

human chorion gonadotropin (hCG)

Intervention Type: BIOLOGICAL

hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690

progesterone

Intervention Type: BIOLOGICAL

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.

placebo-recFSH (follitropin beta)

Intervention Type: DRUG

Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690

open-label recFSH (follitropin beta)

Intervention Type: BIOLOGICAL

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690

recFSH 150 IU

In follow-up study, no medication or investigational product was administered. 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 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.

recFSH (follitropin beta)

Intervention Type: BIOLOGICAL

Daily recFSH administered under protocol P05690

gonadatropin releasing hormone (GnRH) antagonist ganirelix

Intervention Type: DRUG

GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690

human chorion gonadotropin (hCG)

Intervention Type: BIOLOGICAL

hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690

progesterone

Intervention Type: BIOLOGICAL

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.

placebo-corifollitropin alfa

Intervention Type: DRUG

Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690

open-label recFSH (follitropin beta)

Intervention Type: BIOLOGICAL

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690

Interventions

Corifollitropin alfa

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

Intervention Type: DRUG

recFSH (follitropin beta)

Daily recFSH administered under protocol P05690

Intervention Type: BIOLOGICAL

gonadatropin releasing hormone (GnRH) antagonist ganirelix

GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690

Intervention Type: DRUG

human chorion gonadotropin (hCG)

hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690

Intervention Type: 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.

Intervention Type: BIOLOGICAL

placebo-recFSH (follitropin beta)

Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690

Intervention Type: DRUG

placebo-corifollitropin alfa

Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690

Intervention Type: DRUG

open-label recFSH (follitropin beta)

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690

Intervention Type: BIOLOGICAL

Other Intervention Names

SCH 900962; MK-8962; follitropin beta; Puregon®; Follistim®

Eligibility Criteria

Inclusion Criteria

• Participants who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690;
• Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690;
• Able and willing to give written informed consent.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.

Reference Type: DERIVED

PMID: 22587997 (View on PubMed)

Other Identifiers

2006-003812-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

107014

Identifier Type: OTHER

Identifier Source: secondary_id

MK-8962-003

Identifier Type: OTHER

Identifier Source: secondary_id

P05710

Identifier Type: -

Identifier Source: org_study_id