The Use of GnRH Agonist Trigger in the Prevention of OHSS

What Was Tested

This registered phase 4 trial tested Leuprolide.

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.

The registry classes the interventions as drug.

More on the Plan

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.

This is due both to the shorter half-life of the endogenous LH surge and the subsequent pituitary suppression leading to early luteolysis.

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.

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.

Who Took Part

The registry lists 66 planned participants were the target.

It was open to women only aged from 20 years up to 39 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients with either PCOS or PCOM undergoing their first cycle of IVF or patients with high response in a previous IVF cycle.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: hypogonadotropic hypogonadism.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2004-08 with completion listed for 2006-05.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: OHSS occurrence assessed one week after oocyte retrieval. Implantation rate assessed at seven weeks gestation.

It also tracked 3 secondary outcomes, for example Clinical Pregnancy rate assessed at time of ultrasound, Mature oocytes assessed at time of retrieval and Ovarian volume assessed one week after oocyte retrieval.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 66 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.