Luteal-Phase GnRH Agonist Administration in Frozen-Thawed IVF Embryo Transfer Cycles
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 19, 2007 | ||||||||
| Last Updated Date | October 9, 2007 | ||||||||
| Start Date ICMJE | December 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
pregnancy and delivery rates | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00542126 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 | Luteal-Phase GnRH Agonist Administration in Frozen-Thawed IVF Embryo Transfer Cycles | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro Fertilization treatment, but may have a negative effect on uterine function and contribute the fact that the majority of preembryos placed in the uterus fail to implant. Several medical agents were shown to be beneficial when given in the luteal phase of an IVF cycle, but the optimal regimen has not been yet determined. In 2006, a European group reported that addition of GnRH analog (Decapeptyl) as luteal support in IVF cycle significantly improved pregnancy and delivery rates. It is not known whether this positive effect influences the corpus luteum, embryo or the uterus. The researchers sought to evaluate the effect of GnRH administration as luteal support in frozen-thaws IVF cycle. |
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| Detailed Description | Not Provided | ||||||||
| 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 | Pregnancy Rate | ||||||||
| Intervention ICMJE | Drug: Decapeptyl 0.1 mg after embryo transfer
Decapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer |
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| Study Arm (s) |
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| Publications * | Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. Epub 2006 Aug 22. | ||||||||
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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 | Not yet recruiting | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Estimated Completion Date | September 2009 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: IVF patients transfer of a minimum of two medium-quality thawed embryos in IVF Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 38 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00542126 | ||||||||
| Other Study ID Numbers ICMJE | GnRHFETsupport.CTIL | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Shaare Zedek Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Shaare Zedek Medical Center | ||||||||
| Verification Date | September 2007 | ||||||||
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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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