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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 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

July 23, 2009
July 28, 2009
January 2009
December 2009   (final data collection date for primary outcome measure)
Frequency of functional rescue of corpus luteum [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00948805 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • 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
  • 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
  • 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.
    Intervention: Drug: GnRH agonist
  • 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.
    Intervention: Drug: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
July 2010
December 2009   (final data collection date for primary outcome measure)

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
Female
21 Years to 38 Years
Yes
Contact: Cláudia M Gomes, MD 551130596122 cgomes@huntington.com.br
Contact: André M Rocha, PhD 551130596122 arocha@huntington.com.br
Brazil
 
NCT00948805
0555/09
Yes
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)
University of Sao Paulo
Not Provided
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)
University of Sao Paulo
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP