Montelukast for Prevention & Treatment of OHSS

NCT ID: NCT03794037

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Ovarian Hyperstimulation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Dydrogesterone Oral Tablet 10 mg twice daily for 14 days to be taken from the day of ovum pickup

study

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

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

montelukast 10 mg(tab) once daily oral for 7 days \& dydrgesterone 10 mg (tab) twice daily oral for 14 days \&

Interventions

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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

Intervention Type DRUG

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 \&

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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progesterone only

Eligibility Criteria

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Inclusion Criteria

* PCOS high responders high numbers of ovum retrieved

Exclusion Criteria

* hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction
Minimum Eligible Age

20 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hawaa Fertility Center

OTHER

Sponsor Role collaborator

Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Saad

Assistant professor of Ob. & Gyn.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed sa saad, MD, ph D

Role: PRINCIPAL_INVESTIGATOR

Hawaa Fertility Center

Locations

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Banha University- Hawaa Fertility center

Banhā, Qalyubia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Hawaa-5

Identifier Type: -

Identifier Source: org_study_id

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