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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485537
• Other study ID #: RA0001
• Status: Completed
• Phase: N/A
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: September 2005
• Est. completion date: December 2006

Study information

• Verified date: June 2007
• Source: Clinic and Research Center in Human Reproduction Roger Abdelmassih
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2005
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• oocyte retrieval and ICSI procedure

Locations

Country	Name	City	State
Brazil	Clinica e Centro de Reprodução Humana Roger Abdelmassih	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Clinic and Research Center in Human Reproduction Roger Abdelmassih

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative response to ICSI cycles with GnRH agosnist and cetrotide		16 months
Secondary	Compare number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates in both groups		16 months