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Clinical Trials/NCT02173977
NCT02173977
Unknown
Phase 2

Ultrashort Flare GnRH Agonist Combined With Flexible Multidose GnRH Antagonist Versus Flexible Multidose GnRH Antagonist for Good-prognosis IVF Patients

Sheba Medical Center1 site in 1 country200 target enrollmentJune 2014
ConditionsInfertility

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Infertility
Sponsor
Sheba Medical Center
Enrollment
200
Locations
1
Primary Endpoint
Ongoing pregnancy rates
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist protocol.

The investigators hypothesized that combining the stimulatory effect of GnRH agonists and immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH strategy for IVF patients, resulting in improved ART outcome.

Detailed Description

The ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist protocol during COH cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated IVF failures and in poor responders. This protocol combines the effect of the microdose flare on endogenous follicle stimulating hormone (FSH) release with the benefit of an immediate luteinizing hormone suppression of the GnRH antagonist. The basic hypothesis of this approach can also benefit IVF patients with good prognosis without compromising the ability to use gonadotrophin-releasing hormone (GnRH) agonist to effectively trigger ovulation, while completely eliminating any threat of clinically significant ovarian hyperstimulation syndrome (OHSS). The purpose of the study is to compare cycles consisting of ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist with those using the flexible multidose GnRH antagonist protocol 1. To compare the IVF outcome variables and ongoing pregnancy rates.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
May 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Up to three previous IVF attempts

Exclusion Criteria

  • Patients with poor or no response in previous COH for IVF cycles
  • Abnormal ovarian reserve test i.e. anti-mullerian hormone (AMH), Antral follicle test
  • Risk factor for Diminished Ovarian Reserve

Outcomes

Primary Outcomes

Ongoing pregnancy rates

Time Frame: 2 years

Secondary Outcomes

  • Total gonadotropin use(2 Years)
  • Biochemical pregnancy(2 Years)
  • Clinical pregnancy(2 Years)
  • Multiple pregnancy rate(2 Years)
  • Miscarriage rate(2 Years)
  • Fertilization rate(2 Years)
  • Number of oocytes(2 years)
  • OHSS rates(2 Years)
  • Embryo quality(2 Years)

Study Sites (1)

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