Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00702988

Enrollment

Registered

2008-06-20

Start date

2003-10-01

Completion date

2005-02-28

Last updated

2022-02-03

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

Conditions

Pregnancy, Neonates

Keywords

Neonatal outcome, Congenital malformations, In-Vitro Fertilization, Controlled ovarian stimulation, Follow-up

Brief summary

The objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.

Detailed description

This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Interventions

DRUGOrg 36286

single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826)

DRUGrecFSH

150 IU recFSH daily (reference group administered under protocol 38826)

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

Healthy volunteers

Inclusion criteria

* Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at or beyond 10 weeks after ET) after having received at least one dose of either Org 36286 or Puregon®; and * Able and willing to give written informed consent.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Pregnancy status at 20 weeks of gestation	one pregnancy period
Take-home baby rate	one pregnancy period

Secondary

Measure	Time frame
Neonatal outcome	one pregnancy period
Infant follow-up	one pregnancy period
Delivery follow-up	one pregnancy period
Pregnancy follow-up	one pregnancy period
Congenital malformations and chromosomal abnormalities	one pregnancy period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026