The Use of GnRH Agonist Trigger in the Prevention of OHSS

Condition(s) targeted: Ovarian Hyperstimulation Syndrome

Intervention: Leuprolide acetate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Connecticut

Official(s) and/or principal investigator(s):
Claudio Benadiva, MD, Principal Investigator, Affiliation: University of Connecticut
Lawrence Engmann, MD, Principal Investigator, Affiliation: University of Connecticut

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.

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 design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

OHSS occurrence assessed one week after oocyte retrieval

Implantation rate assessed at seven weeks gestation

Secondary outcome:

Clinical Pregnancy rate assessed at time of ultrasound

Mature oocytes assessed at time of retrieval

Ovarian volume assessed one week after oocyte retrieval

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.

Minimum age: 20 Years. Maximum age: 39 Years. Gender(s): Female.

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

Center for Advanced Reproductive Services, UCHC, Farmington, Connecticut 06032, United States

Starting date: August 2004
Ending date: May 2006
Last updated: July 5, 2006