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

Not Applicable

• Conditions: Ovarian Hyperstimulation Syndrome
• Interventions: Drug: cetrorelix (cetrotide); Drug: Placebo

• Registration Number: NCT02392520
• Lead Sponsor: Eugonia

Brief 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.

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-18
• Last Update Submitted: 2015-03-18
• Study First Posted: 2015-03-19
• Last Update Posted: 2015-03-19
• Study Start: 2015-05
• Primary Completion: 2016-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 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),
    • haematocrit (Ht) >45%,
    • white blood cell count (WBC) >15,000/mm3.

Exclusion Criteria

• Women not fulfilling the above criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antagonist	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
Conventional	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Time to severe OHSS regression	2- 21 days after severe OHSS diagnosis

Secondary Outcome Measures

Name	Time	Method
Need for patient hospitalization	2- 21 days after severe OHSS diagnosis
Hematocrit levels	8 days after severe early OHSS diagnosis
Quantity of ascites	8 days after severe early OHSS diagnosis
Estradiol levels	8 days after severe early OHSS diagnosis
White blood cells	8 days after severe early OHSS diagnosis
Diameter of ovaries	8 days after severe early OHSS diagnosis
Serum levels of vascular endothelial growth factor (VEGF)	8 days after severe early OHSS diagnosis
Progesterone levels	8 days after severe early OHSS diagnosis

Trial Locations

Locations (1)

Eugonia Unit of Assisted Reproduction; 🇬🇷 Athens, Greece