Pregnancy and neonatal follow-up of ongoing pregnancies established after controlled ovarian stimulation in clinical trial 107012 for the development of Org 36286 (corifollitropin alfa)
Phase 1
- Conditions
- Controlled Ovarian Stimulation (COS) to induce the development of multiple follicles in patients participating in an Assisted Reproductive Technology (ART) program
- Registration Number
- EUCTR2006-003812-23-CZ
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1. Subjects who participated in trial 107012 and received at least one dose of either Org 36286 or
Puregon®/Follistim® AQ Cartridge in trial 107012;
2. Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in
Trial 107012;
3. Able and willing to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
None.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether 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 subjects and their offspring.;Secondary Objective: ;Primary end point(s): Documentation of complications during pregnancy, mode of delivery, complications during delivery, neonatal outcome including congenital malformations at birth and at a follow-up visit 4 to 12 weeks postpartum (to collect data regarding the infant).
- Secondary Outcome Measures
Name Time Method