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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Trial recruitment is currently suspended

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Dec 2018

Longer than P75 for phase_2

Geographic Reach

1 country

1 active site

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

Study Start

First participant enrolled

December 5, 2018

Completed

28 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed

Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

January 2, 2019

Last Update Submit

September 18, 2022

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

ovarian hyperstimulation syndromeMontelukast

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Number of Participants treated of ovarian hyperstimulation syndrome
0-14 days

Study Arms (2)

control

ACTIVE COMPARATOR

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

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

study

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: progesterone only

control

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

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

study

Eligibility Criteria

Age20 Years - 37 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility Detailsinfertile females undergoing ART cycles

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

PCOS high responders high numbers of ovum retrieved

You may not qualify if:

hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Benha Universitylead
Hawaa Fertility Centercollaborator

Study Sites (1)

Banha University- Hawaa Fertility center

Banhā, Qalyubia Governorate, 13512, Egypt

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

montelukastTablets

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

ahmed sa saad, MD, ph D
Hawaa Fertility Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant professor of Ob. & Gyn.

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 4, 2019

Study Start

December 5, 2018

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP
Time Frame: 6 months
Access Criteria: drahmedsaad@live.com

Locations

EG(1)

Study Stopped

Montelukast for Prevention & Treatment of OHSS

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

control

study

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

control

study

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations