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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00948805
• Other study ID #: 0555/09
• Status: Unknown status
• Phase: Phase 3
• First received: July 23, 2009
• Last updated: July 28, 2009
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2009
• Source: University of Sao Paulo
• Contact: Cláudia M Gomes, MD
• Phone: 551130596122
• Email: cgomes[@]huntington.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 25
• Est. completion date: July 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• GnRH agonist
3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation
• Control
250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation

Locations

Country	Name	City	State
Brazil	Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of functional rescue of corpus luteum		6 months
Secondary	Pregnancy rate		6 months
Secondary	Levels of serum steroids		6 months
Secondary	Levels of serum gonadotropins		6 months

External Links

•   University of São Paulo web page