Progesterone Support of FET (FETProg)
| Tracking Information | |||||
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| First Received Date ICMJE | January 26, 2010 | ||||
| Last Updated Date | May 8, 2013 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinical Pregnancy Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01058382 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Implantation rate [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Progesterone Support of FET | ||||
| Official Title ICMJE | Progesterone Support for Frozen Embryo Transfer: Intramuscular Versus Vaginal Suppository - A Prospective, Randomized, Controlled Trial | ||||
| Brief Summary | There have been two very common forms of progesterone administration that have been used during ovulation induction, in vitro fertilization (IVF) and embryo transfers. There are currently no randomized clinical trials to demonstrate which method of progesterone administration is more effective for frozen embryo transfer. We raise the question: Is there a difference between the two accepted methods of progesterone administration, intramuscular and vaginal suppositories, for frozen embryo transfer? Studies for fresh embryo transfer after in vitro fertilization, have demonstrated that there is not a difference between the two methods of progesterone administration. We will evaluate the question for frozen embryo transfer. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Women having a frozen embryo transfer. |
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| Condition ICMJE | Frozen Embryo Pregnancy Rate | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 57 | ||||
| Completion Date | October 2012 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 20 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01058382 | ||||
| Other Study ID Numbers ICMJE | 09-008006 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Charles Coddington, Mayo Clinic | ||||
| Study Sponsor ICMJE | Charles Coddington | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | May 2013 | ||||
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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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