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Clinical Trials/NCT00571870
NCT00571870
Completed
Not Applicable

Study on the Effect of GnRH Antagonist on hCG Day on Outcomes of Controlled Ovarian Hyperstimulation With GnRH Antagonist Flexible Multiple-dose Protocols

Seoul National University Bundang Hospital1 site in 1 country80 target enrollmentNovember 2007

Overview

Phase
Not Applicable
Intervention
cetrorelix acetate
Conditions
Infertility
Sponsor
Seoul National University Bundang Hospital
Enrollment
80
Locations
1
Primary Endpoint
Maturity of oocytes, fertilization rate, embryo quality
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's.

Many years have passed since GnRH antagonists were introduced to prevent premature LH surges during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group. Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve better follicular and embryonic development and to improve the pregnancy rates in COH using GnRH antagonist.

Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with current protocols, we hypothesized that a shorter duration of GnRH antagonist administration might improve outcome.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
August 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Both ovaries present with no morphological abnormalities
  • Normal ovulatory cycle with cycle lengths of between 25 and 35 days
  • Basal serum FSH (day 3) level of \< 15 mIU/mL
  • Body mass index (BMI) ranging between 18 and 27 kg/m2

Exclusion Criteria

  • History of a poor ovarian response
  • Evidence of endocrine abnormalities, such as, hyperprolactinemia, thyroid dysfunction, or polycystic ovary syndrome
  • Hydrosalpinx
  • Severe endometriosis (stage III-IV)

Arms & Interventions

A

Stimulated as conventional protocol

Intervention: cetrorelix acetate

B

GnRH antagonist stopped one day earlier than conventional protocol

Intervention: cetrorelix acetate

Outcomes

Primary Outcomes

Maturity of oocytes, fertilization rate, embryo quality

Time Frame: 3 days

Study Sites (1)

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