NCT00485537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,005

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

June 11, 2007

Last Update Submit

June 11, 2007

Conditions

Infertility

Keywords

GnRH antagonistGnRH agonistICSImiscarriage ratepregnancy outcome

Outcome Measures

Primary Outcomes (1)

  • Comparative response to ICSI cycles with GnRH agosnist and cetrotide

    16 months

Secondary Outcomes (1)

  • Compare number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates in both groups

    16 months

Interventions

oocyte retrieval and ICSI procedurePROCEDURE

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • use of exogenous LH during stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica e Centro de Reprodução Humana Roger Abdelmassih

São Paulo, São Paulo, 01431-000, Brazil

Location

MeSH Terms

Conditions

Infertility

Interventions

Oocyte Retrieval

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsTissue and Organ HarvestingTransplantationSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Rosa M Neme, MD,PhD

    Clinic and Research Center in Human Reproduction Roger Abdelmassih

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 13, 2007

Study Start

September 1, 2005

Study Completion

December 1, 2006

Last Updated

June 13, 2007

Record last verified: 2007-06

Locations

BR(1)