Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (Care Program)(Study 38834)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00702520

Purpose

The objective of this trial is to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) is safe for pregnant subjects and their offspring.

Condition	Intervention
Pregnancy Neonates	Drug: Org 36286

Drug Information available for: Corifollitropin alfa

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)

Further study details as provided by Organon:

Primary Outcome Measures:

Prenatal diagnosis; Mode of delivery; Neonatal outcome; Safety assessment subjects/mothers and newborns/infants; Major/minor congenital malformations [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	April 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Experimental group I 150 ug Org 36286 (corifollitropin alfa)	Drug: Org 36286 single dose of 100 ug or 150 ug Org 36286 (administered under protocol 38833)
Experimental group II 100 ug Org 36286 (corifollitropin alfa)	Drug: Org 36286 single dose of 100 ug or 150 ug Org 36286 (administered under protocol 38833)

Detailed Description:

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Org 36286 and became pregnant during Trial 38833. For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women with an ongoing pregnancy at least 10 weeks after ET in trial 38833 were enrolled in this trial.

Criteria

Inclusion Criteria:

Subjects who received one dose of Org 36286 in Trial 38833;
Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833;
Able and willing to give written informed consent.

Exclusion Criteria:

None

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	38834
Study First Received:	June 18, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00702520
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Organon:

Neonatal outcome
Congenital malformations
In-Vitro fertilization
Controlled ovarian stimulation
Follow-up

Study placed in the following topic categories:

Congenital Abnormalities

ClinicalTrials.gov processed this record on January 15, 2009