Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Montelukast for Prevention & Treatment of OHSS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794037
Recruitment Status : Unknown
Verified October 2019 by Ahmed Saad, Benha University.
Recruitment status was:  Recruiting
First Posted : January 4, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Hawaa Fertility Center
Information provided by (Responsible Party):
Ahmed Saad, Benha University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome 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 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: control
dydrgesterone 10 mg( tab)/12hs/14 days
 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
Other Name: progesterone only
Experimental: study
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
montelukast 10 mg(tab) once daily oral for 7 days & dydrgesterone 10 mg (tab) twice daily oral for 14 days &


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants who develop ovarian hyperstimulation syndrome [ Time Frame: 0-14 days ]
    incidence


Secondary Outcome Measures :
  1. Number of Participants treated of ovarian hyperstimulation syndrome [ Time Frame: 0-14 days ]
    treatment & resolution


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   infertile females undergoing ART cycles
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCOS high responders high numbers of ovum retrieved

Exclusion Criteria:

  • hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794037


Contacts
Layout table for location contacts
Contact: ahmed sa saad, MD, ph D 02001221709989 drahmedsaad@live.com

Locations
Layout table for location information
Egypt
Banha University- Hawaa Fertility center Recruiting
Banha, Qalyubiya, Egypt, 13512
Contact: Ahmed sa saad, MD, ph D         
Sponsors and Collaborators
Benha University
Hawaa Fertility Center
Investigators
Layout table for investigator information
Principal Investigator: ahmed sa saad, MD, ph D Hawaa Fertility Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ahmed Saad, Assistant professor of Ob. & Gyn., Benha University
ClinicalTrials.gov Identifier: NCT03794037    
Other Study ID Numbers: Hawaa-5
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: study protocol, results,statistics
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 6 months
Access Criteria: drahmedsaad@live.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Saad, Benha University:
ovarian hyperstimulation syndrome
Montelukast
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Hyperstimulation Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Montelukast
Progesterone
Progestins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action