Back to resultsPregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
oocyte retrieval and ICSI procedure
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring GnRH antagonist, GnRH agonist, ICSI, miscarriage rate, pregnancy outcome
Eligibility 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
Sites / Locations
- Clinica e Centro de Reprodução Humana Roger Abdelmassih
Outcomes
Primary Outcome Measures
Comparative response to ICSI cycles with GnRH agosnist and cetrotide
Secondary Outcome Measures
Compare number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates in both groups
Full Information
NCT ID
NCT00485537
First Posted
June 11, 2007
Last Updated
June 11, 2007
Sponsor
Clinic and Research Center in Human Reproduction Roger Abdelmassih
1. Study Identification
Unique Protocol Identification Number
NCT00485537
Brief Title
Pregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Clinic and Research Center in Human Reproduction Roger Abdelmassih
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
GnRH antagonist, GnRH agonist, ICSI, miscarriage rate, pregnancy outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2005 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
oocyte retrieval and ICSI procedure
Primary Outcome Measure Information:
Title
Comparative response to ICSI cycles with GnRH agosnist and cetrotide
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Compare number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates in both groups
Time Frame
16 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa M Neme, MD,PhD
Organizational Affiliation
Clinic and Research Center in Human Reproduction Roger Abdelmassih
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica e Centro de Reprodução Humana Roger Abdelmassih
City
São Paulo
State/Province
SP
ZIP/Postal Code
01431-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Pregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles
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