Follow-up Protocol on the Outcome of Frozen-Thawed Embryo Transfer Cycles From Clinical Trial 107012 (Complete)(Study 107015) - Full Text View

Purpose

Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transer (FTET) cycles performed after the embryos are cryopreserved in Trial 107012 in order to estimate the cumulative pregnancy rate for each treatment group.

Condition	Intervention
In Vitro Fertilization	Drug: corifollitropin alfa Drug: recFSH (follitropin alfa)

ChemIDplus related topics:

Follitropin beta Urofollitropin Corifollitropin alfa Follicle Stimulating Hormone

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other, Prospective

Official Title:	Follow-up Protocol to Collect the Outcome of Frozen-Thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012

Further study details as provided by Organon:

Primary Outcome Measures:

The primary efficacy parameter is the cumulative ongoing pregnancy rate. [ Time Frame: After one or more Frozen-Thawed embryo transfer cycles following cryopreservation. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number and percentage of subjects with a miscarriage, ectopic pregnancy, clinical pregnancy, vital pregnancy and ongoing pregnancy will be calculated per 107012 treatment group and subsequent FTET cycle (i.e. FTET cycle 1, FTET cycle 2, etc). [ Time Frame: After one or more Frozen-Thawed embryo transfer cycles following cryopreservation. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	March 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 Experimental group (Org 36286 (corifollitropin alfa))	Drug: corifollitropin alfa Single injection of 100 μg Org 36286 administered under protocol 107012
Group 2 Reference group (recFSH (follitropin alfa))	Drug: recFSH (follitropin alfa) Daily recFSH administered under protocol 107012

Detailed Description:

This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved in Trial 107012, to enable estimation of the cumulative pregnancy rate for each treatment group.

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 from whom embryos have been cryopreserved in Trial 107012

Criteria

Inclusion Criteria:

Subjects from whom embryos have been cryopreserved in Trial 107012 of which at least one embryo is thawed for use in a subsequent FTET cycle;
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:	107015, EudraCT Number: 2006-003813-42
First Received:	June 18, 2008
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00702546
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; South Korea: Korea Food and Drug Administration (KFDA); Taiwan: Department of Health

Keywords provided by Organon:

In-vitro fertilization

Controlled Ovarian Stimulation

Cumulative pregnancy data

Follow-up

Study placed in the following topic categories:

Follicle Stimulating Hormone

Additional relevant MeSH terms:

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2008

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00702546