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Completed

NCT Number: NCT00702195

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)

The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.

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Key information

Conditions

Pregnancy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

About this study

This was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during any Phase IIa clinical trial of Org 36286 for OI or COH for IVF. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa;
  • Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation;
  • Able and willing to give written informed consent.

Exclusion criteria

  • None

Treatment and study plan

Org 36286 (corifollitropin alfa)

Drug

single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807

Other names: corifollitropin alfa

Placebo

Drug

single dose of placebo (administered under protocol 38805)

recFSH

Drug

150 IU recFSH daily (reference group administered under protocol 38807)

Other names: follitropin beta, Puregon®, Follistim®

Primary outcomes

  1. Pregnancy status at 20 weeks of gestation; Take-home baby rate

    Time frame: one pregnancy period

Secondary outcomes

  1. Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities

    Time frame: one pregnancy period

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Jun 20, 2008
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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