Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?

What Was Tested

This registered phase 4 trial tested Triptorelin.

Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation.

The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.

It had 1 arm (groups): OHSS high risk patients (experimental).

The registry classes the interventions as drug.

More on the Plan

In high responder patients with potential risk of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without obtaining (cryopreserved) embryos for replacement.

An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist instead of hCG.

This method is not possible following a long GnRH agonist protocol which causes down-regulation of the GnRH receptor.

However, following GnRH antagonist treatment the GnRH receptor remains receptive to competitive binding by a GnRH agonist.

Who Took Part

6 actual participants took part.

It was open to women only aged from 18 years up to 42 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A female patient who needs IVF to become pregnant. Regular menstrual cycle. Antral follicular count (AFC) \> 18. Following treatment with follitropin beta more than 18 follicles ≥ 11 mm will develop.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: hypersensitivity to the active substance or to any of the medications used; tumors of the ovary, breast, uterus, pituitary or hypothalamus; abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-11 with completion listed for 2014-01.

It ran at 1 site in Israel.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval (time frame: 12 day from GnRH agonist trigger day).

It also tracked 1 secondary outcome, for example Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Triptorelin in 6 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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