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

This study has been completed.
Sponsor:
Information provided by:
Clinic and Research Center in Human Reproduction Roger Abdelmassih
ClinicalTrials.gov Identifier:
NCT00485537
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Infertility
Procedure: oocyte retrieval and ICSI procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Pregnancy Outcomes With a Gonadotropin-Releasing Hormone (GnRH) Antagonist (Cetrorelix) Protocol Versus GnRH-Agonist Protocol in Ovarian Stimulation for ICSI Cycles-a Prospective Study

Resource links provided by NLM:


Further study details as provided by Clinic and Research Center in Human Reproduction Roger Abdelmassih:

Primary Outcome Measures:
  • Comparative response to ICSI cycles with GnRH agosnist and cetrotide [ Time Frame: 16 months ]

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

Enrollment: 2005
Study Start Date: September 2005
Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   22 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00485537

Locations
Brazil
Clinica e Centro de Reprodução Humana Roger Abdelmassih
São Paulo, SP, Brazil, 01431-000
Sponsors and Collaborators
Clinic and Research Center in Human Reproduction Roger Abdelmassih
Investigators
Principal Investigator: Rosa M Neme, MD,PhD Clinic and Research Center in Human Reproduction Roger Abdelmassih
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00485537     History of Changes
Other Study ID Numbers: RA0001
Study First Received: June 11, 2007
Last Updated: June 11, 2007
Health Authority: Brazil: Ministry of Health

Keywords provided by Clinic and Research Center in Human Reproduction Roger Abdelmassih:
GnRH antagonist
GnRH agonist
ICSI
miscarriage rate
pregnancy outcome

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Deslorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014