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Pregnancy and neonatal follow-up of ongoing pregnancies established after controlled ovarian stimulation in clinical trial 38819 for 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
MedDRA version: 7.1 Level: LLT Classification code 10017399
Registration Number
EUCTR2004-004772-36-BE
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 received at least one dose of either Org 36286 or Puregon®/Follistim® AQ Cartridge in Trial 38819;
2. Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38819;
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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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