NCT02392520

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

GnRH Antagonist in the Luteal Phase Compared to Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS) in Whom All Embryos Are Cryopreserved

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Eugonia · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. The approach has been described as tertiary OHSS prevention, thereby complementing the primary prevention (GnRH antagonist protocol) and secondary prevention (GnRH agonist trigger) that constitute the OHSS-free clinic concept. 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.

Conditions

• Ovarian Hyperstimulation Syndrome

Interventions

Type	Name	Description
DRUG	cetrorelix (cetrotide)	0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis
DRUG	Placebo	intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-03-01
• Completion: 2016-12-01
• First posted: 2015-03-19
• Last updated: 2015-03-19

Locations

1 site across 1 country: Greece