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Clinical Trials/NCT00461422
NCT00461422
Completed
Phase 4

Early Follicular GnRH Antagonist Supplementation Improves Fertilization and Embryo Cleavage Rates in IVF-ET GnRH Antagonist Cycles

The Baruch Padeh Medical Center, Poriya1 site in 1 country50 target enrollmentJanuary 2004
InterventionsGanirelix

Overview

Phase
Phase 4
Intervention
Ganirelix
Conditions
Infertility
Sponsor
The Baruch Padeh Medical Center, Poriya
Enrollment
50
Locations
1
Primary Endpoint
pregnancy rates
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results

Detailed Description

GnRH antagonist offers many advantages when used in IVF-ET treatment, however, it is suspected to yield lower pregnancy rate when compared with the long GnRH agonist protocol. Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results. Consecutive patients are prospectively enrolled and randomly assigned to the study and control groups. Patients with low ovarian reserve or with uterine distortion are excluded from the study. Both groups are treated with recombinant FSH and the flexible GnRH antagonist protocol. Women in the study group are also treated with additional GnRH antagonist 0.25 mg/day on day 1, 2 and 3 of the menstrual cycle.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
June 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • infertility
  • IVF candidate
  • failure of previous IVF attempt

Exclusion Criteria

  • low ovarian reserve
  • untreated distortion of uterine cavity
  • medical contraindication for IVF treatment

Arms & Interventions

1

Standard Flexible antagonist protocol Addition of Ganirelix at first 3 days of the cycle

Intervention: Ganirelix

Outcomes

Primary Outcomes

pregnancy rates

Time Frame: one cycle

Secondary Outcomes

  • differences in hormonal levels(one cycle)
  • differences in the basic treatment doses(one cycle)
  • oocyte counts(one cycle)
  • fertilization rate(one cycle)
  • cleavage rate(one cycle)

Study Sites (1)

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