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

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

cetrorelix (cetrotide)

Placebo

About this trial

This is an interventional treatment trial for Ovarian Hyperstimulation Syndrome focused on measuring severe OHSS, antagonist administration, conventional treatment

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Eugonia Unit of Assisted Reproduction

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Antagonist

Conventional

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Time to severe OHSS regression

Secondary Outcome Measures

Need for patient hospitalization

Hematocrit levels

White blood cells

Diameter of ovaries

Quantity of ascites

Estradiol levels

Progesterone levels

Serum levels of vascular endothelial growth factor (VEGF)

Full Information

NCT ID

NCT02392520

First Posted

March 13, 2015

Last Updated

March 18, 2015

Sponsor

Eugonia

1. Study Identification

Unique Protocol Identification Number

NCT02392520

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eugonia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Hyperstimulation Syndrome

Keywords

severe OHSS, antagonist administration, conventional treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antagonist

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

cetrorelix (cetrotide)

Other Intervention Name(s)

GnRH antagonist

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

conventional treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to severe OHSS regression

Time Frame

2- 21 days after severe OHSS diagnosis

Secondary Outcome Measure Information:

Title

Need for patient hospitalization

Time Frame

2- 21 days after severe OHSS diagnosis

Title

Hematocrit levels

Time Frame