Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 107012 (Care Program) (Study 107014) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00702624

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: recFSH

Drug Information available for: Follitropin beta Urofollitropin Corifollitropin alfa Follicle Stimulating Hormone

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 107012 for the Development of 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:	140
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 100 μg Org 36286 (corifollitropin alfa)	Drug: Org 36286 single dose of 150 μg Org 36286 (experimental group administered under protocol 107012)
Group II 150 IU recFSH (follitropin beta)	Drug: recFSH 150 IU recFSH daily (reference group administered under protocol 107012)

Detailed Description:

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with Org 36286 or recFSH and became pregnant during Trial 107012. 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 36 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 embryo transfer in Trial 107012 were enrolled in this trial.

Criteria

Inclusion Criteria:

Subjects who participated in trial 107012 and received at least one dose of either Org 36286 or Puregon®/Follistim® AQ Cartridge in trial 107012;
Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 107012;
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:	107014, P05710
Study First Received:	June 18, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00702624
Health Authority:	Austria: Federal Office for Safety in Health Care; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Spain: Ministry of Health and Consumption; France: Afssaps - French Health Products Safety Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Sweden: Medical Products Agency

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
Follicle Stimulating Hormone

ClinicalTrials.gov processed this record on January 15, 2009