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

Phase 3

• Conditions: Infertility
• Interventions: Drug: GnRH agonist; Drug: Control

• Registration Number: NCT00948805
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-07
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-28
• Last Update Submitted: 2009-07-28
• Study First Posted: 2009-07-29
• Last Update Posted: 2009-07-29
• Primary Completion: 2009-12
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GnRH agonist	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.
Control	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.

Primary Outcome Measures

Name	Time	Method
Frequency of functional rescue of corpus luteum	6 months

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	6 months
Levels of serum steroids	6 months
Levels of serum gonadotropins	6 months

Trial Locations

Locations (1)

Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo; 🇧🇷 São Paulo, Brazil