Montelukast for Prevention & Treatment of OHSS

Benha University

Status and phase: Suspended; Phase 2

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: dydrgesterone 10 mg( tab)/12hs/14 days; Combination Product: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days

Study type: Interventional

Funder types: Other

Identifiers

NCT03794037

Hawaa-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 20 to 37 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PCOS high responders high numbers of ovum retrieved

Exclusion criteria

• hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

control

Active Comparator group

Description:

dydrgesterone 10 mg( tab)/12hs/14 days

Treatment:

Drug: dydrgesterone 10 mg( tab)/12hs/14 days

study

Experimental group

Description:

montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days

Treatment:

Combination Product: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days