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The Use of GnRH Agonist Trigger in the Prevention of OHSS
This study has been completed.
First Received: July 5, 2006   No Changes Posted
Sponsor: University of Connecticut
Collaborator: Organon
Information provided by: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00349258
  Purpose

To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic gonadotropin (hCG) to trigger final oocyte maturation.


Condition Intervention Phase
Ovarian Hyperstimulation Syndrome
Drug: Leuprolide acetate
Phase IV

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Prospective Randomized Study Comparing the Use of hCG or GnRH Agonist to Trigger Final Oocyte Maturation in High Responders Undergoing in-Vitro Fertilization Treatment

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • OHSS occurrence assessed one week after oocyte retrieval
  • Implantation rate assessed at seven weeks gestation

Secondary Outcome Measures:
  • Clinical Pregnancy rate assessed at time of ultrasound
  • Mature oocytes assessed at time of retrieval
  • Ovarian volume assessed one week after oocyte retrieval

Estimated Enrollment: 66
Study Start Date: August 2004
Estimated Study Completion Date: May 2006
Detailed Description:

OHSS is an iatrogenic complication of controlled ovarian hyperstimulation, which in its severe form, may result in significant morbidity. Although, there have been significant advances in in-vitro fertilization (IVF) protocols over the years, the incidence of OHSS have remained stable and there is currently no effective way of preventing this disorder.

hCG is commonly used as a substitute for the endogenous LH surge to induce final oocyte maturation in IVF. Unfortunately, hCG results in a prolonged luteotropic effect because of its long half-life which may result in a potential risk of OHSS in high-risk patients. In contrast, induction of endogenous LH surge with a GnRH agonist may result in a reduced risk of OHSS. This is due both to the shorter half-life of the endogenous LH surge and the subsequent pituitary suppression leading to early luteolysis. However, previous studies have suggested that this approach may impair implantation rates.

There are no randomized studies assessing the effect of GnRH agonist to induce oocyte maturation on the occurrence of OHSS and implantation rates in high-risk patients. The aims of this study are to compare the incidence of OHSS and implantation rates among high-risk patients who used either GnRH agonist or hCG to trigger oocyte maturation after prevention of premature LH surge with either a GnRH antagonist protocol or the dual pituitary suppression protocol, respectively.

High risk patients include women with polycystic ovarian syndrome (PCOS) or PCO morphology (PCOM) on ultrasound without the clinical or biochemical evidence of the syndrome, and patients with previous high response to gonadotropins.

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 20-39
  • normal early follicular phase serum FSH (≤10.0 IU/l)
  • patients with either PCOS or PCOM undergoing their first cycle of IVF or patients with high response in a previous IVF cycle.

Exclusion Criteria:

  • Hypogonadotropic hypogonadism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349258

Locations
United States, Connecticut
Center for Advanced Reproductive Services, UCHC
Farmington, Connecticut, United States, 06032
Sponsors and Collaborators
University of Connecticut
Organon
Investigators
Principal Investigator: Claudio Benadiva, MD University of Connecticut Health Center
Principal Investigator: Lawrence Engmann, MD University of Connecticut Health Center
  More Information

No publications provided

Study ID Numbers: 04-277
Study First Received: July 5, 2006
Last Updated: July 5, 2006
ClinicalTrials.gov Identifier: NCT00349258     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
OHSS
PCOS
Previous high response
GnRH antagonist
GnRH agonist
IVF

Additional relevant MeSH terms:
Disease
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
Reproductive Control Agents
Ovarian Diseases
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Deslorelin
Pathologic Processes
Leuprolide
Fertility Agents, Female
Therapeutic Uses
Syndrome
Ovarian Hyperstimulation Syndrome
Fertility Agents

ClinicalTrials.gov processed this record on February 08, 2010