Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

Overview

To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH agonist /GnRH antagonist protocol

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2015

Detailed Description

The combined ultrashort flare GnRH agonist /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 is a protocol combining the effect of the microdose flare on endogenous FSH release with the benefit of an immediate LH suppression of the GnRH antagonist. A major disadvantage of the use of a GnRH antagonist protocol is the limitation for programming cycles, as the drugs administration is started on day 2 of the menstrual cycle and is strictly followed until the hCG criteria are met. The purpose of the study is to perform oestradiol pre-treatment with the combined ultrashort flare GnRH agonist /GnRH antagonist protocol aiming to 1. better programme an antagonist cycle and 2. improve the IVF outcome parameters, from the production of more follicles / oocytes up to the rise in live birth rates.

Interventions

  • Procedure: Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol
  • Procedure: GnRH agonist or antagonist protocol without oestradiol pre-treatment

Arms, Groups and Cohorts

  • Experimental: Oestradiol and ultrashort GnRH agonist/antagonist protocol
    • Women will begin pretreatment with 4 mg/day of 17 β-estradiol before the combination of GnRH ultashort agonist and antagonist protocol
  • Active Comparator: GnRH agonist or antagonist protocol.
    • Women will undergo either a conventional short or long GnRH agonist or an antagonist protocol during COH for IVF

Clinical Trial Outcome Measures

Primary Measures

  • Live birth rate
    • Time Frame: 2 years
  • Clinical pregnancy rate
    • Time Frame: 2 years

Secondary Measures

  • Number of oocytes retrieved
    • Time Frame: 2 years
  • Top embryo quality at day 2
    • Time Frame: 2 years
  • Biochemical pregnancy
    • Time Frame: 2 years
  • Ectopic pregnancy
    • Time Frame: 2 years
  • Miscarriage rate
    • Time Frame: 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with poor or no response in previous COH for IVF cycles – Patients with AMH < 1 and/or FSH >12 – Poor quality of embryos in previous cycles – Age of patients up to 44 years Exclusion Criteria:

  • Patients with normal ovarian reserve – Patients with sonographically detected hydrosalpinges – Presence of intramural fibroid distorting the endometrial cavity or submucous myoma or Asherman's syndrome – Women with thrombofilia disorders

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: 44 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National and Kapodistrian University of Athens
  • Provider of Information About this Clinical Study
    • Principal Investigator: Siristatidis Charalampos, MD, PhD, Assistant Professor in Obstetrics and Gynecology/Assisted Reproduction – National and Kapodistrian University of Athens
  • Overall Official(s)
    • George Salamalekis, MD, PhD, Principal Investigator, National and Kapodistrian University of Athens
    • Charalampos Siristatidis, Assistant Professor, Principal Investigator, National and Kapodistrian University of Athens

References

Griesinger G, Kolibianakis EM, Venetis C, Diedrich K, Tarlatzis B. Oral contraceptive pretreatment significantly reduces ongoing pregnancy likelihood in gonadotropin-releasing hormone antagonist cycles: an updated meta-analysis. Fertil Steril. 2010 Nov;94(6):2382-4. doi: 10.1016/j.fertnstert.2010.04.025. Epub 2010 May 26.

Bosch E. Can we skip weekends in GnRH antagonist cycles without compromising the final outcome? Fertil Steril. 2012 Jun;97(6):1299-300. doi: 10.1016/j.fertnstert.2012.04.024. No abstract available.

Citations Reporting on Results

Orvieto R, Nahum R, Rabinson J, Gemer O, Anteby EY, Meltcer S. Ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist for patients with repeated IVF failures and poor embryo quality. Fertil Steril. 2009 Apr;91(4 Suppl):1398-400. doi: 10.1016/j.fertnstert.2008.04.064. Epub 2008 Aug 3.

Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.

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