- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00485537
Pregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles
June 11, 2007 updated by: Clinic and Research Center in Human Reproduction Roger Abdelmassih
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
Intervention / Treatment
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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