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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Drug: cetrorelix (cetrotide)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antagonist<br>0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis | Drug: cetrorelix (cetrotide)<br>* 0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis<br>* Other names: GnRH antagonist;|
| Placebo Comparator: Conventional<br>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. | Drug: Placebo<br>* intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume<br>* Other names: conventional treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to severe OHSS regression |  | 2- 21 days after severe OHSS diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for patient hospitalization |  | 2- 21 days after severe OHSS diagnosis | 
| Hematocrit 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 | 
| Quantity of ascites |  | 8 days after severe early OHSS diagnosis | 
| Estradiol levels |  | 8 days after severe early OHSS diagnosis | 
| Progesterone levels |  | 8 days after severe early OHSS diagnosis | 
| Serum levels of vascular endothelial growth factor (VEGF) |  | 8 days after severe early OHSS diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe OHSS, antagonist administration, conventional treatment