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-FR
- 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
- Secondary Outcome Measures
Name Time Method