Follow-up Protocol on the Outcome of Frozen-Thawed Embryo Transfer Cycles From Clinical Trial 107012 (Complete)(Study 107015)(COMPLETED)(P05711) - Tabular View

Tracking Information
First Received Date ^ICMJE	June 18, 2008
Last Updated Date	October 1, 2009
Start Date ^ICMJE	March 2007
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 18, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00702546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 18, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Follow-up Protocol on the Outcome of Frozen-Thawed Embryo Transfer Cycles From Clinical Trial 107012 (Complete)(Study 107015)(COMPLETED)(P05711)
Official Title ^ICMJE	Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012
Brief Summary	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.
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.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Other, Prospective
Condition ^ICMJE	In Vitro Fertilization
Intervention ^ICMJE	Drug: corifollitropin alfa Drug: recFSH (follitropin alfa)
Study Arms / Comparison Groups	Experimental group (Org 36286 (corifollitropin alfa)) Reference group (recFSH (follitropin alfa))
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	150
Completion Date	October 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 36 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00702546
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	107015, EudraCT #: 2006-003813-42;, P05711
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP