Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
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| First Received Date ICMJE | May 10, 2011 | ||||||||
| Last Updated Date | March 30, 2012 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up. [ Time Frame: 12 months ] [ Designated as safety issue: No ] Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01353846 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients | ||||||||
| Official Title ICMJE | Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients | ||||||||
| Brief Summary | The purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program. |
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| Detailed Description | Oocyte donation is an assisted reproduction technique well established. In patients with ovarian function, it is necessary to synchronize the cycle of the egg donor with the recipient, usually through endometrial preparation of the recipient by artificial cycle, by administering a GnRH agonist on day 21 of cycle and then administered increasing doses of estrogen therapy to achieve adequate endometrial thickness. The necessity of synchronization between donors and recipient, has made possible not routinely the natural cycle for oocyte donation. The investigators have recently introduced oocyte vitrification and it allows us to plan the egg donation in a different way. Now the investigators can previously cryopreserved donor oocytes and at the time that the investigators have a compatible receiver, then, plan the donation In this study it will be possible compare the results of oocyte donation cycles in terms of pregnancy rate, implantation and liveborn, depending on whether the recipient has made an artificial cycle of preparation endometrial or a natural cycle. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| 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 |
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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 | 70 | ||||||||
| Estimated Completion Date | November 2012 | ||||||||
| Estimated Primary Completion Date | November 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 44 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Spain | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01353846 | ||||||||
| Other Study ID Numbers ICMJE | 0901-C-055-MF | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dra. Pilar Alamá, IVI Valencia | ||||||||
| Study Sponsor ICMJE | Instituto Valenciano de Infertilidad, Spain | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Instituto Valenciano de Infertilidad, Spain | ||||||||
| Verification Date | March 2012 | ||||||||
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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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