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Completed

NCT Number: NCT00702988

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

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.

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Key information

Conditions

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

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 Trial 38826. 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 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

Treatment and study plan

Org 36286

Drug

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

Other names: Corifollitropin alfa

recFSH

Drug

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

Other names: Follitropin Beta, Puregon®, Follistim®

Primary outcomes

  1. Pregnancy status at 20 weeks of gestation

    Time frame: one pregnancy period

  2. Take-home baby rate

    Time frame: one pregnancy period

Secondary outcomes

  1. Pregnancy follow-up

    Time frame: one pregnancy period

  2. Delivery follow-up

    Time frame: one pregnancy period

  3. Neonatal outcome

    Time frame: one pregnancy period

  4. Infant follow-up

    Time frame: one pregnancy period

  5. 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 Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jun 20, 2008
Registry last updated
Feb 3, 2022

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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