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Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Yazd Research & Clinical Center for Infertility.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier:
NCT00823602
First received: January 13, 2009
Last updated: January 14, 2009
Last verified: January 2009
  Purpose

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 .


Condition Intervention Phase
Infertility
Drug: ganirelix
Drug: suprefact
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART

Resource links provided by NLM:


Further study details as provided by Yazd Research & Clinical Center for Infertility:

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: 2weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ovarian stimulation [ Time Frame: 10days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2
Study Start Date: March 2008
Estimated Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823602

Contacts
Contact: razieh firouzabadi, MD 8247085 ext +98351 dr_firouzabadi@yahoo.com
Contact: shahnaz Ahmadi, MD 9173717981 ext +98 AHMADISHAHNAZ2005@yahoo.com

Locations
Iran, Islamic Republic of
Yazd Research and Clinical Center For Infertility Recruiting
Yazd, Iran, Islamic Republic of
Contact: razieh firouzabadi, MD    8247085 ext +98351    dr_firouzabadi@yahoo.com   
Contact: shahnaz Ahmadi, MD    9173717981 ext +98    AHMADISHAHNAZ2005@yahoo.com   
Principal Investigator: shahnaz ahmadi, MD         
Sponsors and Collaborators
Yazd Research & Clinical Center for Infertility
Investigators
Study Chair: razieh firouzabadi, MD Yazd Research & Clinical Center for Infertility
  More Information

No publications provided

Responsible Party: Razieh Dehghani Firouzabadi, Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier: NCT00823602     History of Changes
Other Study ID Numbers: 1387YAZDRCCI
Study First Received: January 13, 2009
Last Updated: January 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yazd Research & Clinical Center for Infertility:
GnRH antagonist
GnRH agonist
pregnancy rate
Ovarian stimulation

Additional relevant MeSH terms:
Genital Diseases, Male
Infertility
Genital Diseases, Female
Deslorelin
Ganirelix
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014