Clinical trial NCT00349258: The Use of GnRH Agonist Trigger in the Prevention of OHSS
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: OHSS
PCOS
Previous high response
GnRH antagonist
GnRH agonist
IVF
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2006-07-06
Enrollment: 66
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: OHSS occurrence assessed one week after oocyte retrieval
measure: Implantation rate assessed at seven weeks gestation
Secondary outcomes:
measure: Clinical Pregnancy rate assessed at time of ultrasound
measure: Mature oocytes assessed at time of retrieval
measure: Ovarian volume assessed one week after oocyte retrieval
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Center for Advanced Reproductive Services, UCHC
state: Connecticut
Study officials:
affiliation: UConn Health
name: Claudio Benadiva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UConn Health
name: Lawrence Engmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.