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

August 4, 2015 updated by: Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH agonist /GnRH antagonist protocol

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 12642
        • Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: Oestradiol pre-treatment and combination of GnRH agonist/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
Procedure: GnRH agonist or antagonist protocol without oestradiol pre-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 2 years
2 years
Live birth rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Positive Pregnancy Test
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: George Salamalekis, MD, PhD, National and Kapodistrian University of Athens
  • Principal Investigator: Charalampos Siristatidis, Assistant Professor, National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030675

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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