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Luteal-Phase GnRH Agonist Administration in Frozen-Thawed IVF Embryo Transfer Cycles

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ClinicalTrials.gov Identifier: NCT00542126
Recruitment Status : Unknown
Verified September 2007 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 10, 2007
Last Update Posted : October 10, 2007
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE September 19, 2007
First Posted Date  ICMJE October 10, 2007
Last Update Posted Date October 10, 2007
Study Start Date  ICMJE December 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October¬†9,¬†2007)
pregnancy and delivery rates
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Arms  ICMJE
  • Active Comparator: 1
    GnRH analog administration following embryo transfer
    Intervention: Drug: Decapeptyl 0.1 mg after embryo transfer
  • No Intervention: 2
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE 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:

  1. Two or more fresh IVF embryo transfer or three or more thawed embryos transfer with no pregnancy.
  2. maximal endometrial thickness < 6 mm or intracavitary fluid at the time of embryo transfer on previous cycles
  3. Untreated hydrosalpinges
  4. intracavitary mass
  5. submucous myoma
  6. known allergy to one of medical agents used in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00542126
Other Study ID Numbers  ICMJE GnRHFETsupport.CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Avi Tsafrir, MD Shaare-Zedek Medical Center, Jerusalem, Israel
PRS Account Shaare Zedek Medical Center
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP