Montelukast for Prevention & Treatment of OHSS
Primary Purpose
Ovarian Hyperstimulation Syndrome
Status
Suspended
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
dydrgesterone 10 mg( tab)/12hs/14 days
montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring ovarian hyperstimulation syndrome, Montelukast
Eligibility Criteria
Inclusion Criteria:
- PCOS high responders high numbers of ovum retrieved
Exclusion Criteria:
- hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction
Sites / Locations
- Banha University- Hawaa Fertility center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
study
Arm Description
dydrgesterone 10 mg( tab)/12hs/14 days
montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
Outcomes
Primary Outcome Measures
Number of Participants who develop ovarian hyperstimulation syndrome
incidence
Secondary Outcome Measures
Number of Participants treated of ovarian hyperstimulation syndrome
treatment & resolution
Full Information
NCT ID
NCT03794037
First Posted
January 2, 2019
Last Updated
September 18, 2022
Sponsor
Benha University
Collaborators
Hawaa Fertility Center
1. Study Identification
Unique Protocol Identification Number
NCT03794037
Brief Title
Montelukast for Prevention & Treatment of OHSS
Official Title
Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Suspended
Why Stopped
no fund
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
Collaborators
Hawaa Fertility Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
ovarian hyperstimulation syndrome, Montelukast
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
dydrgesterone 10 mg( tab)/12hs/14 days
Arm Title
study
Arm Type
Experimental
Arm Description
montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
Intervention Type
Drug
Intervention Name(s)
dydrgesterone 10 mg( tab)/12hs/14 days
Other Intervention Name(s)
progesterone only
Intervention Description
Dydrogesterone Oral Tablet 10 mg twice daily for 14 days to be taken from the day of ovum pickup
Intervention Type
Combination Product
Intervention Name(s)
montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
Intervention Description
montelukast 10 mg(tab) once daily oral for 7 days & dydrgesterone 10 mg (tab) twice daily oral for 14 days &
Primary Outcome Measure Information:
Title
Number of Participants who develop ovarian hyperstimulation syndrome
Description
incidence
Time Frame
0-14 days
Secondary Outcome Measure Information:
Title
Number of Participants treated of ovarian hyperstimulation syndrome
Description
treatment & resolution
Time Frame
0-14 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
infertile females undergoing ART cycles
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PCOS high responders high numbers of ovum retrieved
Exclusion Criteria:
hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed sa saad, MD, ph D
Organizational Affiliation
Hawaa Fertility Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha University- Hawaa Fertility center
City
Banha
State/Province
Qalyubiya
ZIP/Postal Code
13512
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol, results,statistics
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
drahmedsaad@live.com
Learn more about this trial
Montelukast for Prevention & Treatment of OHSS
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