GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles

August 14, 2007 updated by: V.K.V. American Hospital, Istanbul
A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles was reported to increase pregnancy and birth rates. This study was done to evaluate the reproducibility of previous findings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the long GnRH agonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.

Study Type

Interventional

Enrollment (Actual)

570

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

  • Turkey
      • Istanbul, Turkey, 34365
        • Amerikan Hastanesi Tüp Bebek Merkezi

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 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol, oocyte pick-up and ICSI.
  • Embryo transfer performed on day 3.

Exclusion Criteria:

  • Participation in another trial that was being conducted in our unit at the same time.
  • Preimplantation genetic screening cycles.
  • Day 5 embryo transfers.

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
GnRH agonist administration
Drug: triptorelin acetate
Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
Other Names:
  • Decapeptyl Ferring GmBH Kiel Germany
PLACEBO_COMPARATOR: 2
Sterile saline injection
Drug: Na Cl %0.9
0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer
Other Names:
  • Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ongoing pregnancy rate beyond 20 weeks

Secondary Outcome Measures

Outcome Measure
Clinical pregnancy
Embryo implantation rate

Collaborators and Investigators

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

Sponsor

V.K.V. American Hospital, Istanbul

Investigators

  • Principal Investigator: Baris Ata, M.D., The Assisted Reproduction Unit of the American Hospital of Istanbul
  • Study Director: Bulent Urman, M.D., The Assisted Reproduction Unit of the American Hospital of Istanbul

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

September 1, 2006

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (ESTIMATE)

August 15, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2007

Last Update Submitted That Met QC Criteria

August 14, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH-47/07

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.

Clinical Trials on Infertility

Clinical Trials on triptorelin acetate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe