The Use of GnRH Agonist Trigger in the Prevention of OHSS

Sponsor
University of Connecticut (Other)
Overall Status
Completed
CT.gov ID
NCT00349258
Collaborator
Organon (Industry)
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Leuprolide acetate
Phase 4

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Study Start Date :
Aug 1, 2004
Study Completion Date :
May 1, 2006

Outcome Measures

Primary Outcome Measures

  1. OHSS occurrence assessed one week after oocyte retrieval []

  2. Implantation rate assessed at seven weeks gestation []

Secondary Outcome Measures

  1. Clinical Pregnancy rate assessed at time of ultrasound []

  2. Mature oocytes assessed at time of retrieval []

  3. Ovarian volume assessed one week after oocyte retrieval []

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Center for Advanced Reproductive Services, UCHC Farmington Connecticut United States 06032

Sponsors and Collaborators

  • University of Connecticut
  • Organon

Investigators

  • Principal Investigator: Claudio Benadiva, MD, UConn Health
  • Principal Investigator: Lawrence Engmann, MD, UConn Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00349258
Other Study ID Numbers:
  • 04-277
First Posted:
Jul 6, 2006
Last Update Posted:
Jul 6, 2006
Last Verified:
Feb 1, 2006

Study Results

No Results Posted as of Jul 6, 2006