The Use of GnRH Agonist Trigger in the Prevention of OHSS

NCT ID: NCT00349258

Last Updated: 2006-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2006-05-31

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.

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.

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

OHSS; PCOS; Previous high response; GnRH antagonist; GnRH agonist; IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Leuprolide acetate

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon

INDUSTRY

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Principal Investigators

Claudio Benadiva, MD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Lawrence Engmann, MD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

Center for Advanced Reproductive Services, UCHC

Farmington, Connecticut, United States

Countries

United States

References

Engmann L, Romak J, Nulsen J, Benadiva C, Peluso J. In vitro viability and secretory capacity of human luteinized granulosa cells after gonadotropin-releasing hormone agonist trigger of oocyte maturation. Fertil Steril. 2011 Jul;96(1):198-202. doi: 10.1016/j.fertnstert.2011.04.071. Epub 2011 May 20.

Reference Type: DERIVED

PMID: 21601197 (View on PubMed)

Other Identifiers

04-277

Identifier Type: -

Identifier Source: org_study_id