A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs
| Tracking Information | |||||
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| First Received Date ICMJE | August 25, 2011 | ||||
| Last Updated Date | August 25, 2011 | ||||
| Start Date ICMJE | January 2006 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
endometrial thickness measured by ultrasound [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ] In office ultrasound to measure thickness of endometrial lining. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
endometrial biopsy [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ] In office aspiration of endometrial cells will be examined microscopically to determine if they are at an appropriate stage for implantation. |
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| 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 | A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs | ||||
| Official Title ICMJE | A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles | ||||
| Brief Summary | This study compares two different methods to prepare the uterine lining of recipients for implantation in cycles using donor eggs. The study method requires less time than the standard method. It is hypothesized that both methods would be suitable for use in egg donor cycles. |
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| Detailed Description | Currently a combination of medications is used to prepare the uterine lining of recipients for implantation in egg donor cycles. The protocol used most commonly is as follows: Initially the individual's own pituitary-ovarian system is suppressed using a GnRH agonist so there are not conflicting signals sent to the uterus. This is followed by hormonal medication identical to what is secreted by the ovaries to prepare the uterine lining for subsequent embryo transfer in donor egg cycles.This preparation typically takes a minimum of four weeks. This study will compare a different medication, a GnRh antagonist (which is commonly used in IVF) to suppress an individual's system during the preparation of the uterine lining. This protocol would generally take only two weeks to prepare the uterine lining. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Implantation, Embryo | ||||
| Intervention ICMJE |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | September 2012 (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 52 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01424618 | ||||
| Other Study ID Numbers ICMJE | 39604 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Maureen Kelly, M.D., Kelly, Maureen, M.D. | ||||
| Study Sponsor ICMJE | Kelly, Maureen, M.D. | ||||
| Collaborators ICMJE | Merck | ||||
| Investigators ICMJE |
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| Information Provided By | Kelly, Maureen, M.D. | ||||
| Verification Date | August 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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