MedTrace Logo

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

NCT00702624 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 113

Last updated 2022-02-03

Study results available
· View outcomes & findings →

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.

Conditions

  • Pregnancy
  • Neonates

Interventions

DRUG

Corifollitropin alfa

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

BIOLOGICAL

recFSH (follitropin beta)

Daily recFSH administered under protocol P05690

DRUG

gonadatropin releasing hormone (GnRH) antagonist ganirelix

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

BIOLOGICAL

human chorion gonadotropin (hCG)

hCG 5,000 IU/USP or 10,000 IU/USP administered 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 beta)

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

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 (follitropin beta)

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-04-30
Completion
2008-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00702624 on ClinicalTrials.gov