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

NCT00702988 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2022-02-03

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Neonates

Interventions

DRUG

Org 36286

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

DRUG

recFSH

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-01
Primary Completion
2005-02-28
Completion
2005-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00702988 on ClinicalTrials.gov