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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 | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Active, not recruiting |
| Enrollment † | 150 |
| Start Date † | March 2007 |
| Completion Date | December 2008 |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| 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 |