Luteal-Phase GnRH Agonist Administration in Frozen-Thawed IVF Embryo Transfer Cycles

October 9, 2007 updated by: Shaare Zedek Medical Center

Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro Fertilization treatment, but may have a negative effect on uterine function and contribute the fact that the majority of preembryos placed in the uterus fail to implant.

Several medical agents were shown to be beneficial when given in the luteal phase of an IVF cycle, but the optimal regimen has not been yet determined. In 2006, a European group reported that addition of GnRH analog (Decapeptyl) as luteal support in IVF cycle significantly improved pregnancy and delivery rates. It is not known whether this positive effect influences the corpus luteum, embryo or the uterus. The researchers sought to evaluate the effect of GnRH administration as luteal support in frozen-thaws IVF cycle.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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
      • Jerusalem, Israel, 91031
        • IVF unit, Shaare-Zedek Medical Center

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 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

IVF patients transfer of a minimum of two medium-quality thawed embryos in IVF

Exclusion Criteria:

  1. Two or more fresh IVF embryo transfer or three or more thawed embryos transfer with no pregnancy.
  2. maximal endometrial thickness < 6 mm or intracavitary fluid at the time of embryo transfer on previous cycles
  3. Untreated hydrosalpinges
  4. intracavitary mass
  5. submucous myoma
  6. known allergy to one of medical agents used in the study

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
No Intervention: 2
Active Comparator: 1
GnRH analog administration following embryo transfer
Drug: Decapeptyl 0.1 mg after embryo transfer
Decapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pregnancy and delivery rates

Collaborators and Investigators

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

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Avi Tsafrir, MD, Shaare-Zedek Medical Center, Jerusalem, Israel

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

December 1, 2007

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

October 10, 2007

Last Update Submitted That Met QC Criteria

October 9, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GnRHFETsupport.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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