Pregnancy and neonatal follow-up of ongoing pregnancies established after controlled ovarian stimulation in clinical trial 38819 for Org 36286 (corifollitropin alfa)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004772-36-FI

Enrollment

Unknown

Registered

2006-04-10

Start date

2006-06-30

Completion date

Unknown

Last updated

2019-06-30

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this trial is 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).	—

Measure

Time frame

Main Objective: The objective of this trial is 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).

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Countries

Belgium, Czech Republic, Finland, Spain, Sweden, United Kingdom

Outcome results

None listed

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