Ovarian Hyperstimulation Syndrome Prevention (OHSS)

December 13, 2024 updated by: Mahmoud Alalfy, Aljazeera Hospital

Prophylaxis Against Ovarian Hyperstimulation Syndrome in PCOS Women

Ovarian hyperstimulation is a very hazardous complication of ICSI

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ovarian hyperstimulation could be mild , moderate , severe or marked

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Algazeerah
        • Contact:
        • Contact:
          • Ahmed Elgazzar, M.D
          • Phone Number: +201014005959
        • Principal Investigator:
          • Mahmoud Alalfy, master
      • Giza, Egypt, 12345
        • Recruiting
        • Aljazeerah hospital
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women with PCOS coming for ICSI

Exclusion Criteria:

  • Women who donnot have PCOS

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: antagonist
patients with PCOS undergoing ICSI receiving antagonist protocol
Drug: Antagonist protocol for IVF
antagonist protocol with triggering by Decapeptyl
Other Names:
  • Antagonist
Active Comparator: Modified agonist with additives
Patients with PCOS undergoing ICSI receiving modified agonist protocol with additives
Drug: Modified Agonist protocol for IVF with additive treatments as HCQ
giving additive drugs to agonist protocolas HCQ
Other Names:
  • modified agonist with additives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevention of OHSS
Time Frame: within 3 weeks
prevention of symptoms of ovarian hyperstimulation syndrome as amount of ascites in litres by US
within 3 weeks

Collaborators and Investigators

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

Sponsor

Aljazeera Hospital

Investigators

  • Study Chair: Mahmoud Alalfy, MD, Aljazeera Hospital

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 (Actual)

November 17, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ovarian hyperstimulation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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