Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS)

What Was Tested

This registered not phased trial tested Cetrorelix.

The study aims to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment in IVF patients who develop severe early ovarian hyperstimulation syndrome and have all their embryos cryopreserved.

It had two arms (groups): Antagonist (experimental) and Conventional (placebo comparator).

Women with severe early OHSS will be treated with conventional treatment, such as intravenous albumin administration, paracentesis of ascitic fluid, either on an outpatient or inpatient basis.

The registry classes the interventions as drug.

More on the Plan

GnRH antagonist administration in the luteal phase has been proposed as a strategy for the treatment of established severe early OHSS, causing rapid regression of the syndrome on an outpatient basis.

No randomized controlled trials (RCT) exist to date comparing luteal GnRH antagonist administration versus conventional treatment.

The aim of the present study is to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment with primary outcome time to severe OHSS regression, in IVF patients who develop severe early OHSS and have all their embryos cryopreserved.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to women only aged from 18 years up to 49 years.

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

Examples of who could join: Women with established severe early OHSS. Criteria for the diagnosis of severe OHSS require:. The presence of moderate (or higher) ascites and at least two of the following:. Enlarged ovaries (\>100 mm maximal diameter),. White blood cell count (WBC) \>15,000/mm3.

The full record lists 6 inclusion and 1 exclusion criteria; among the exclusions: women not fulfilling the above criteria.

How the Study Was Run

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

The participants were allocated by chance, so the Cetrorelix group and the comparison group should start out alike.

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

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

It started in 2015-05 with completion listed for 2016-03.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to severe OHSS regression (time frame: 2- 21 days after severe OHSS diagnosis).

It also tracked 8 secondary outcomes, for example Need for patient hospitalization, Hematocrit levels, White blood cells, Diameter of ovaries, Quantity of ascites and Estradiol levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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