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| 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 |
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 |
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 |
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| Study Arms / Comparison Groups |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| 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:
Exclusion Criteria:
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| 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 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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