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

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00702988

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Neonates	Drug: Org 36286 Drug: recFSH

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.

Study Design

Study Type:

Observational

Actual Enrollment :

44 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2003

Actual Primary Completion Date :

Feb 28, 2005

Actual Study Completion Date :

Feb 28, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental Group 1 all doses of Org 36286 (corifollitropin alfa) (60 μg, 120 μg and 180 μg)	Drug: Org 36286 single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826) Other Names: Corifollitropin alfa
Experimental Group 2 150 IU recFSH	Drug: recFSH 150 IU recFSH daily (reference group administered under protocol 38826) Other Names: Follitropin Beta, Puregon®, Follistim®

Arm

Intervention/Treatment

Experimental Group 1

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

Drug: Org 36286

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

Other Names:

Corifollitropin alfa

Experimental Group 2

150 IU recFSH

Drug: recFSH

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

Other Names:

Follitropin Beta, Puregon®, Follistim®

Outcome Measures

Primary Outcome Measures

Pregnancy status at 20 weeks of gestation [one pregnancy period]
Take-home baby rate [one pregnancy period]

Secondary Outcome Measures

Pregnancy follow-up [one pregnancy period]
Delivery follow-up [one pregnancy period]
Neonatal outcome [one pregnancy period]
Infant follow-up [one pregnancy period]
Congenital malformations and chromosomal abnormalities [one pregnancy period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts 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.