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

March 18, 2015 updated by: Eugonia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Eugonia Unit of Assisted Reproduction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eugonia

Investigators

  • Principal Investigator: George T Lainas, MD, Barts and The London NHS Trust (ART Unit)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • luteal antag OHSS RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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