Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)
- Registration Number
- NCT00702988
- Lead Sponsor
- Organon and Co
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 44
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental Group 1 Org 36286 all doses of Org 36286 (corifollitropin alfa) (60 μg, 120 μg and 180 μg) Experimental Group 2 recFSH 150 IU recFSH
- Primary Outcome Measures
Name Time Method Pregnancy status at 20 weeks of gestation one pregnancy period Take-home baby rate one pregnancy period
- Secondary Outcome Measures
Name Time Method Infant follow-up one pregnancy period Pregnancy follow-up one pregnancy period Congenital malformations and chromosomal abnormalities one pregnancy period Delivery follow-up one pregnancy period Neonatal outcome one pregnancy period