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Clinical Trials/NCT00948805
NCT00948805
Unknown
Phase 3

Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment

University of Sao Paulo1 site in 1 country25 target enrollmentJanuary 2009

Overview

Phase
Phase 3
Intervention
GnRH agonist
Conditions
Infertility
Sponsor
University of Sao Paulo
Enrollment
25
Locations
1
Primary Endpoint
Frequency of functional rescue of corpus luteum
Last Updated
16 years ago

Overview

Brief Summary

This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.

Detailed Description

The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
July 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • age \>21 and \< 38 years old
  • polycystic ovarian syndrome
  • risk for ovarian hyperstimulation syndrome

Exclusion Criteria

  • recurrent abortion
  • endometriosis
  • more than 3 IVF failures
  • use of oral contraceptive pills in the preceding 3 months
  • low response to gonadotropins

Arms & Interventions

GnRH agonist

3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.

Intervention: GnRH agonist

Control

250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.

Intervention: Control

Outcomes

Primary Outcomes

Frequency of functional rescue of corpus luteum

Time Frame: 6 months

Secondary Outcomes

  • Pregnancy rate(6 months)
  • Levels of serum steroids(6 months)
  • Levels of serum gonadotropins(6 months)

Study Sites (1)

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