Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF

June 23, 2014 updated by: Sheba Medical Center

Ultrashort Flare GnRH Agonist Combined With Flexible Multidose GnRH Antagonist Versus Flexible Multidose GnRH Antagonist for Good-prognosis IVF Patients

The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist protocol.

The investigators hypothesized that combining the stimulatory effect of GnRH agonists and immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH strategy for IVF patients, resulting in improved ART outcome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The ultrashort flare GnRH agonist combined with flexible multidose 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 protocol combines the effect of the microdose flare on endogenous follicle stimulating hormone (FSH) release with the benefit of an immediate luteinizing hormone suppression of the GnRH antagonist.

The basic hypothesis of this approach can also benefit IVF patients with good prognosis without compromising the ability to use gonadotrophin-releasing hormone (GnRH) agonist to effectively trigger ovulation, while completely eliminating any threat of clinically significant ovarian hyperstimulation syndrome (OHSS).

The purpose of the study is to compare cycles consisting of ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist with those using the flexible multidose GnRH antagonist protocol

1. To compare the IVF outcome variables and ongoing pregnancy rates.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

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

  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center- IVF unit

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

18 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Up to three previous IVF attempts

Exclusion Criteria:

  • Patients with poor or no response in previous COH for IVF cycles
  • Abnormal ovarian reserve test i.e. anti-mullerian hormone (AMH), Antral follicle test
  • Risk factor for Diminished Ovarian Reserve

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
Active Comparator: ARM A- Agonist/Antagonist protocol
The Ultrashort GnRH Agonist/antagonist method entails pre-treatment with oral contraceptive pills before the combination of GnRH ultrashort agonist and antagonist protocol
Other: ARM A- Agonist/Antagonist protocol
In vitro fertilization (IVF/ICSI)
Other: ARM B- Antagonist protocol
In vitro fertilization (IVF/ICSI)
Active Comparator: ARM B- Antagonist protocol
The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH
Other: ARM A- Agonist/Antagonist protocol
In vitro fertilization (IVF/ICSI)
Other: ARM B- Antagonist protocol
In vitro fertilization (IVF/ICSI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy rates
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total gonadotropin use
Time Frame: 2 Years
2 Years
Biochemical pregnancy
Time Frame: 2 Years
Positive pregnancy test without documentation of intrauterine or extrauterine pregnancy
2 Years
Clinical pregnancy
Time Frame: 2 Years
Positive pregnancy test with documentation of intrauterine or extrauterine pregnancy
2 Years
Multiple pregnancy rate
Time Frame: 2 Years
2 Years
Miscarriage rate
Time Frame: 2 Years
2 Years
Fertilization rate
Time Frame: 2 Years
2 Years
Number of oocytes
Time Frame: 2 years
2 years
OHSS rates
Time Frame: 2 Years
2 Years
Embryo quality
Time Frame: 2 Years

Grading of a day 3 embryo based on the number of cells that make up the embryo, the amount of fragmentation, and the symmetry of each of the embryo's cells (blastomeres).

E.g. good quality embryos: embryos that reach the eight-cell stage with less than 20% fragmentation on day 3
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

Sheba Medical Center

Investigators

  • Principal Investigator: Raoul Orvieto, MD, Infertility & IVF Unit, Dept. Obstetrics & Gynecology - Director

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

June 1, 2014

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-14-1078-RO-CTIL

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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