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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2005 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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oocyte retrieval and ICSI procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Rosa M Neme, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Clinic and Research Center in Human Reproduction Roger Abdelmassih

Locations

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Clinica e Centro de Reprodução Humana Roger Abdelmassih

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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RA0001

Identifier Type: -

Identifier Source: org_study_id