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

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

This study is ongoing, but not recruiting participants.

Study NCT00702546. Last updated on November 24, 2008. Information provided by Organon

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Descriptive Information Fields
Brief Title ^†	Follow-up Protocol on the Outcome of Frozen-Thawed Embryo Transfer Cycles From Clinical Trial 107012 (Complete)(Study 107015)
Official Title ^†	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 ^†	Observational
Study Design ^†	Other, Prospective
Primary Outcome Measure ^†	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 Measure ^†	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 ]
Condition ^†	In Vitro Fertilization
Intervention ^†	Drug: corifollitropin alfa Drug: recFSH (follitropin alfa)
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	150
Start Date ^†	March 2007
Completion Date	December 2008
Eligibility 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
Gender	Female
Ages	18 Years to 36 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†

Administrative Information Fields
NCT ID ^†	NCT00702546
Organization ID	107015
Secondary IDs ^††	EudraCT #: 2006-003813-42;, P05711
Study Sponsor ^†	Organon
Collaborators ^††
Investigators ^†
Information Provided By	Organon
Verification Date	November 2008
First Received Date ^†	June 18, 2008
Last Updated Date	November 24, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.