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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by University of Sao Paulo.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT00948805

First received: July 23, 2009

Last updated: July 28, 2009

Last verified: July 2009

History of Changes

Purpose

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	Intervention	Phase
Infertility	Drug: GnRH agonist Drug: Control	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Infertility

Drug Information available for: Chorionic Gonadotropin Gonadorelin Gonadorelin hydrochloride Deslorelin Goserelin Goserelin acetate Choriogonadotropin Alfa

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Frequency of functional rescue of corpus luteum [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pregnancy rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Levels of serum steroids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Levels of serum gonadotropins [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility

Ages Eligible for Study:	21 Years to 38 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948805

Contacts

Contact: Cláudia M Gomes, MD	551130596122	cgomes@huntington.com.br
Contact: André M Rocha, PhD	551130596122	arocha@huntington.com.br

Locations

Brazil
Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo	Recruiting
São Paulo, Brazil, 05403000
Contact: Cláudia Gomes, MD 551176569373 cgomes@huntington.com.br
Principal Investigator: Cláudia Gomes, MD

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)

More Information

Additional Information:

University of São Paulo web page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Cláudia Messias Gomes, Gynecology of Faculty of Medicine of the University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)
ClinicalTrials.gov Identifier:	NCT00948805 History of Changes
Other Study ID Numbers:	0555/09
Study First Received:	July 23, 2009
Last Updated:	July 28, 2009
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

corpus luteum rescue
Gonadotropin Releasing Hormone (GnRH agonist)
human Chorionic Gonadotropin (hCG)
infertility
pregnancy rate

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Triptorelin
Hormones
Deslorelin
Luteolytic Agents
Goserelin
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents, Female
Contraceptive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013

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