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

Phase 2

Terminated

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

• Registration Number: NCT01798836
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-26
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH agonist or antagonist protocol.	GnRH agonist or antagonist protocol without oestradiol pre-treatment	Women will undergo either a conventional short or long GnRH agonist or an antagonist protocol during COH for IVF
Oestradiol and ultrashort GnRH agonist/antagonist protocol	Oestradiol pre-treatment and combination of 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

Primary Outcome Measures

Name	Time	Method
Live birth rate	2 years
Clinical pregnancy rate	2 years

Secondary Outcome Measures

Name	Time	Method
Ectopic pregnancy	2 years
Miscarriage rate	2 years
Top embryo quality at day 2	2 years
Number of oocytes retrieved	2 years
Biochemical pregnancy	2 years

Trial Locations

Locations (1)

Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital; 🇬🇷 Athens, Attica, Greece