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Pregnancy and neonatal follow-up of ongoing pregnancies established after controlled ovarian stimulation in clinical trial 38825 for Org 36286 (corifollitropin alfa)

Pregnancy and neonatal follow-up of ongoing pregnancies established after controlled ovarian stimulation in clinical trial 38825 for Org 36286 (corifollitropin alfa)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004967-30-SE
Enrollment
Unknown
Registered
2006-09-01
Start date
2006-11-01
Completion date
Unknown
Last updated
2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Product Name: corifollitropin alfa Product Code: Org 36286 Pharmaceutical Form: Solution for injection INN or Proposed INN: corifollitropin alfa CAS Number: 195962-23-3 Current Sponsor code: Org 36286

Sponsors

NV Organon
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who received at least one dose of Org 36286 in Trial 38825; 2. Ongoing pregnancy confirmed by ultrasound at least 10 weeks after a fresh embryo transfer in Trial 38825; 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

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
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).—

Countries

France, Germany, Hungary, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026