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Clinical Trials/NCT00417066
NCT00417066
Completed
Phase 4

The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders

Eugonia1 site in 1 country270 target enrollmentSeptember 2003

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Infertility
Sponsor
Eugonia
Enrollment
270
Locations
1
Primary Endpoint
Ongoing pregnancy rate per embryo transfer
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes compared to the flare up protocol in this group of patients.

Detailed Description

Poor responders are women who fail to respond effectively to the usual gonadotropin stimulation protocol applied in an IVF cycle. It seems that a diminished ovarian reserve is the principal factor of poor ovarian response. Several strategies have been proposed for the management of poor responders, including flare up GnRH agonist regimens and the GnRH antagonist, which presents a new hope in this group of patients. Comparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or flare up agonist (Arvekap) protocol. Primary outcomes compared will be ongoing pregnancy rates in the two treatment groups.

Registry
clinicaltrials.gov
Start Date
September 2003
End Date
July 2006
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Eugonia

Eligibility Criteria

Inclusion Criteria

  • regular menstrual cycle
  • 1 or more failed IVF attempts with poor response
  • 5 or fewer oocytes retrieved
  • FSH\>12 IU/l on day 3

Exclusion Criteria

  • Normal responders

Outcomes

Primary Outcomes

Ongoing pregnancy rate per embryo transfer

Secondary Outcomes

  • Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.
  • Number of mature oocytes retrieved.
  • Number of fertilised oocytes.

Study Sites (1)

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