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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948805
First Posted: July 29, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  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
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

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 ]

Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: 6 months ]
  • Levels of serum steroids [ Time Frame: 6 months ]
  • Levels of serum gonadotropins [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 38 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: July 23, 2009
First Posted: July 29, 2009
Last Update Posted: October 12, 2017
Last Verified: July 2009

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
Hormones
Deslorelin
Triptorelin Pamoate
Luteolytic Agents
Goserelin
Chorionic Gonadotropin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents