Pregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles

Pregnancy Outcomes With a Gonadotropin-Releasing Hormone (GnRH) Antagonist (Cetrorelix) Protocol Versus GnRH-Agonist Protocol in Ovarian Stimulation for ICSI Cycles-a Prospective Study

Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates, were analized.

Study Overview

Status

Completed

Conditions

Detailed Description

160 women were equally divided between a GnRH antagonist protocol (Group 1) versus a GnRH agonist protocol (Group 2) in ICSI cycles. The trial was conducted between September 2005 and December 2006. The mean age in both groups was 32 (range 22-40). The main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates.

Study Type

Interventional

Enrollment (Actual)

2005

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

    • SP
      • São Paulo, SP, Brazil, 01431-000
        • Clinica e Centro de Reprodução Humana Roger Abdelmassih

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

22 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Infertility couples, absence of endometriosis (confirmed by a previous surgical procedure to investigate infertility), polycystic ovarian syndrome, FSH levels < 12 IU/l, basal levels of estradiol < 20 in the group submitted to the agonist protocol and beginning of stimulation on day 2 in group submitted to antagonist protocol, in the absence of ovarian cysts on the endovaginal ultrasound

Exclusion Criteria:

  • use of exogenous LH during stimulation

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparative response to ICSI cycles with GnRH agosnist and cetrotide
Time Frame: 16 months
16 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates in both groups
Time Frame: 16 months
16 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Rosa M Neme, MD,PhD, Clinic and Research Center in Human Reproduction Roger Abdelmassih

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, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (Estimate)

June 13, 2007

Study Record Updates

Last Update Posted (Estimate)

June 13, 2007

Last Update Submitted That Met QC Criteria

June 11, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA0001

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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