Montelukast for Prevention & Treatment of OHSS

Phase 2

Suspended

• Conditions: Ovarian Hyperstimulation Syndrome
• Interventions: Combination Product: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days; Drug: dydrgesterone 10 mg( tab)/12hs/14 days

• Registration Number: NCT03794037
• Lead Sponsor: Benha University

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.

Study Timeline

• Study Start: 2018-12-05
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-18
• Last Update Posted: 2022-09-21
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• PCOS high responders high numbers of ovum retrieved

Exclusion Criteria

• hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study	montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days	montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
control	dydrgesterone 10 mg( tab)/12hs/14 days	dydrgesterone 10 mg( tab)/12hs/14 days

Primary Outcome Measures

Name	Time	Method
Number of Participants who develop ovarian hyperstimulation syndrome	0-14 days	incidence

Secondary Outcome Measures

Name	Time	Method
Number of Participants treated of ovarian hyperstimulation syndrome	0-14 days	treatment \& resolution

Trial Locations

Locations (1)

Banha University- Hawaa Fertility center; 🇪🇬 Banha, Qalyubiya, Egypt