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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Ovarian Hyperstimulation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antagonist

0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis

Group Type EXPERIMENTAL

cetrorelix (cetrotide)

Intervention Type DRUG

0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis

Conventional

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume

Interventions

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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

Intervention Type DRUG

Placebo

intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume

Intervention Type DRUG

Other Intervention Names

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GnRH antagonist conventional treatment

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.