Day of Embryo Transfer for Patients Undergoing In Vitro Fertilization
| Tracking Information | |||||
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| First Received Date ICMJE | February 1, 2008 | ||||
| Last Updated Date | July 21, 2011 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pregnancy rates [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Pregnancy rates | ||||
| Change History | Complete list of historical versions of study NCT00615771 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Day of Embryo Transfer for Patients Undergoing In Vitro Fertilization | ||||
| Official Title ICMJE | Embryo Transfer on Day 2 vs. Day 3 After Oocyte Retrieval in Patients Who Plan to Replace All Embryos After an In Vitro Fertilization Cycle | ||||
| Brief Summary | We are examining whether pregnancy rates differ based on day of embryo transfer in patients who replace all available embryos after an IVF cycle. Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation). |
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| Detailed Description | The decision on the number of embryos to transfer after an IVF cycle is based on the number of available embryos, the quality of the embryos, the patient's age, and the goal of limiting multiple gestations. Stanford Fertility Center and most IVF centers examine the embryos on the third day after oocyte (egg) retrieval to select for the best quality embryos to transfer, and depending on quality, the remaining embryos are frozen to be used in the future. Patients with a limited number of embryos, those that plan to replace all available embryos after an IVF cycle, do not need to wait until the third day after oocyte retrieval to select embryos, and may replace the embryos on the second day after the oocyte retrieval. We are examining whether pregnancy rates differ among these patients based on the day of embryo transfer (Day 2 vs. Day3). Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Infertility | ||||
| Intervention ICMJE | Procedure: Day of embryo transfer
Women receive their embryo transfer 1 day earlier than standard of care. |
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| Study Arm (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 | 242 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients undergoing fresh IVF cycle at Stanford Fertility Center who plan on replacing all available embryos. Exclusion Criteria: Patients that do not meet above criteria. |
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| Gender | Female | ||||
| Ages | 18 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 | NCT00615771 | ||||
| Other Study ID Numbers ICMJE | SU-01312008-991 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Ruth Lathi, Principle Investigator, Stanford University School of Medicine | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | July 2011 | ||||
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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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