Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

Overview

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.

Full Title of Study: “The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

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.

Interventions

  • Drug: Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)
  • Drug: Arvekap 0.1mg (Triptorelin, Ipsen, France)

Clinical Trial Outcome Measures

Primary Measures

  • Ongoing pregnancy rate per embryo transfer

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eugonia
  • Overall Official(s)
    • Tryfon Lainas, PhD, Study Director, Eugonia

References

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. doi: 10.1093/humupd/dmg007.

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