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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-10-01

Study Completion Date

2005-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pregnancy Neonates

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental Group 1

all doses of Org 36286 (corifollitropin alfa) (60 μg, 120 μg and 180 μg)

Org 36286

Intervention Type DRUG

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

Experimental Group 2

150 IU recFSH

recFSH

Intervention Type DRUG

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

Interventions

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Org 36286

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

Intervention Type DRUG

recFSH

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

Intervention Type DRUG

Other Intervention Names

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Corifollitropin alfa Follitropin Beta, Puregon®, Follistim®

Eligibility Criteria

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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.