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

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00948805

Collaborator

(none)

Enrollment

Location

Arms

17.9

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: GnRH agonist Drug: Control	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 Other Names: Ovidrel Zoladex Gonal
Active Comparator: 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.	Drug: Control 250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation Other Names: Zoladex Ovidrel Gonal

Arm

Intervention/Treatment

Experimental: 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.

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

Other Names:

Ovidrel

Zoladex

Gonal

Active Comparator: 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.

Drug: Control

250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation

Other Names:

Zoladex

Ovidrel

Gonal

Outcome Measures

Primary Outcome Measures

Frequency of functional rescue of corpus luteum [6 months]

Secondary Outcome Measures

Pregnancy rate [6 months]
Levels of serum steroids [6 months]
Levels of serum gonadotropins [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo	São Paulo		Brazil	05403000

Sponsors and Collaborators

University of Sao Paulo

Investigators

Study Chair: Paulo Serafini, PhD, Gynecology of Faculty of Medicine of University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)