Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

January 14, 2009 updated by: Yazd Research & Clinical Center for Infertility

Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART

Literature suggests that GnRH antagonists are comparatively more often used in cycles which have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder patients. Up to now, however not enough prospectives have been published to prove any beneficial effect of antagonists on the first cycle assisted reproductive technique.

This prospective study will do to evaluate the efficacy of gonadotropin releasing hormone antagonist in comparison with the standard long protocol in the first cycle of ART.

The investigators will randomize 160 patients undergoing ART for the first time . Group 1 (n=80) was stimulate with a standard long protocol and group 2 (n=80) stimulated with GnRH antagonist and then result of ART compare in two group .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • 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 Contact

Study Contact Backup

Study Locations

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

No older than 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • first cycle of ART
  • age < 35 years
  • basal FSH < 10 IU/L

Exclusion Criteria:

  • previous IVF or ICSI, hyperprolactinemia, hyperthyroidism, hypothyroidism, uterine abnormality, severe endometriosis
  • only one ovary

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: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
GnRH antagonist "ganirelix" 0.25 mg fromm 6th ovarian stimulation
Drug: ganirelix
These patients started ovarian stimulation with 150 - 225 IU Gonal F on the second day of menstrual cycle with an S.C. injection once a day. Initiation of 0.25 mg Ganirelix took place on the 6th of the stimulation (fixed protocol) when HMG (Menogon, ferring, pharmacenticals , Germany ).
ACTIVE_COMPARATOR: 2
GnRH agonist, suprefact, stimulation with a standard long protocol
Drug: suprefact
GnRH agonist, standard protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: 2weeks
2weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ovarian stimulation
Time Frame: 10days
10days

Collaborators and Investigators

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

Sponsor

Yazd Research & Clinical Center for Infertility

Investigators

  • Study Chair: razieh firouzabadi, MD, Yazd Research & Clinical Center for Infertility

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

March 1, 2008

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ANTICIPATED)

January 1, 2009

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (ESTIMATE)

January 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2009

Last Update Submitted That Met QC Criteria

January 14, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1387YAZDRCCI

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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