Montelukast for Prevention & Treatment of OHSS

September 18, 2022 updated by: Ahmed Saad, Benha University

Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles

montelukast & dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

patients with high risk for ovarian hyperstimulation will undergo a freeze-all protocol then montelukast & dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

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

  • Egypt
    • Qalyubiya
      • Banha, Qalyubiya, Egypt, 13512
        • Banha University- Hawaa Fertility center

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

20 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • PCOS high responders high numbers of ovum retrieved

Exclusion Criteria:

  • hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
dydrgesterone 10 mg( tab)/12hs/14 days
Drug: dydrgesterone 10 mg( tab)/12hs/14 days
Dydrogesterone Oral Tablet 10 mg twice daily for 14 days to be taken from the day of ovum pickup
Other Names:
  • progesterone only
Experimental: study
montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
Combination product: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
montelukast 10 mg(tab) once daily oral for 7 days & dydrgesterone 10 mg (tab) twice daily oral for 14 days &

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who develop ovarian hyperstimulation syndrome
Time Frame: 0-14 days
incidence
0-14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants treated of ovarian hyperstimulation syndrome
Time Frame: 0-14 days
treatment & resolution
0-14 days

Collaborators and Investigators

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

Sponsor

Benha University

Collaborators

Hawaa Fertility Center

Investigators

  • Principal Investigator: ahmed sa saad, MD, ph D, Hawaa Fertility Center

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)

December 5, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 18, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hawaa-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol, results,statistics

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

drahmedsaad@live.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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