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

Organon

Status: Completed

Conditions: Neonates; Pregnancy

Treatments: Biological: open-label recFSH (follitropin beta); Biological: progesterone; Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Biological: human chorion gonadotropin (hCG); Biological: recFSH (follitropin beta); Drug: placebo-corifollitropin alfa; Drug: Corifollitropin alfa; Drug: placebo-recFSH (follitropin beta)

Study type: Observational

Funder types: Industry

Identifiers

NCT00702624

MK-8962-003 (Other Identifier)

P05710

107014 (Other Identifier)

2006-003812-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

113 participants in 2 patient groups

Corifollitropin alfa 100 μg

Description:

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.

Treatment:

Drug: placebo-recFSH (follitropin beta)

Drug: Corifollitropin alfa

Biological: human chorion gonadotropin (hCG)

Biological: open-label recFSH (follitropin beta)

Biological: progesterone

Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix

recFSH 150 IU

Description:

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.

Treatment:

Biological: recFSH (follitropin beta)

Drug: placebo-corifollitropin alfa

Biological: human chorion gonadotropin (hCG)

Biological: open-label recFSH (follitropin beta)

Biological: progesterone

Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix