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NCT03794037 Clinical Trial

Montelukast for Prevention & Treatment of OHSS

Ovarian Hyperstimulation Syndrome Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT03794037
Other study ID # Hawaa-5
Secondary ID
Status Suspended
Phase Phase 2
First received
Last updated
Start date December 5, 2018
Est. completion date December 2023

Study information
Verified date September 2022
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Suspended
Enrollment 20
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 37 Years
Eligibility Inclusion Criteria: - PCOS high responders high numbers of ovum retrieved Exclusion Criteria: - hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction

Study Design

Related Conditions & MeSH terms

  • Ovarian Hyperstimulation Syndrome
  • Syndrome

Intervention

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
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 &

Locations
Country Name City State
Egypt Banha University- Hawaa Fertility center Banha Qalyubiya

Sponsors (2)
Lead Sponsor Collaborator
Benha University Hawaa Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants who develop ovarian hyperstimulation syndrome incidence 0-14 days
Secondary Number of Participants treated of ovarian hyperstimulation syndrome treatment & resolution 0-14 days
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Active, not recruiting NCT05638529 - Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome Phase 4
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Completed NCT01815138 - Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS Phase 4
Completed NCT00867659 - The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors N/A
Completed NCT01569256 - Ovarian Hyperstimulation Syndrome and Cabergoline N/A