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
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 20, 2014