Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)
Information source: Organon
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy; Neonates
Intervention: Org 36286 (Drug); recFSH (Drug)
Phase: N/A
Status: Completed
Sponsored by: Organon
Summary
The objective of this trial was to evaluate whether Org 36286 treatment for the induction of
multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro
fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant
subjects and their offspring.
Clinical Details
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).
Study design: Other, Prospective
Primary outcome: Pregnancy status at 20 weeks of gestation
Take-home baby rate
Secondary outcome: Pregnancy follow-up
Delivery follow-up
Neonatal outcome
Infant follow-up
Congenital Malformations and Chromosomal Abnormalities
Detailed description:
This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal
outcome of women who became pregnant during Trial 38826. For this trial, no study specific
assessments were required, but information obtained in standard practice was used.
Eligibility
Minimum age: 18 Years.
Maximum age: 39 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at
or beyond 10 weeks after ET) after having received at least one dose of either Org
36286 or Puregon®; and
- Able and willing to give written informed consent.
Exclusion Criteria:
- None
Locations and Contacts
Additional Information
Starting date: October 2003
Ending date: February 2005
Last updated: June 18, 2008
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