Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders
Information source: Eugonia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility; Premature Ovarian Failure
Intervention: Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) (Drug); Arvekap 0.1mg (Triptorelin, Ipsen, France) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eugonia Official(s) and/or principal investigator(s):
Tryfon Lainas, PhD, Study Director, Affiliation: Eugonia
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.
Clinical Details
Official title: The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Ongoing pregnancy rate per embryo transfer
Secondary outcome: Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.Number of mature oocytes retrieved. Number of fertilised oocytes.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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:
- PCOS
- Normal responders
Locations and Contacts
Eugonia, Athens 11528, Greece
Additional Information
Related publications: Tarlatzis BC, Zepiridis L, Grimbizis G, Bontis J. Clinical management of low ovarian response to stimulation for IVF: a systematic review. Hum Reprod Update. 2003 Jan-Feb;9(1):61-76. Review.
Starting date: September 2003
Ending date: July 2006
Last updated: December 28, 2006
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