Ovarian Hyperstimulation SyndromePhase 2NCT03794037
Montelukast for Prevention & Treatment of OHSS
A Phase 2 study testing dydrgesterone 10 mg( tab)/12hs/14 days and montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days in people with Ovarian Hyperstimulation Syndrome, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- dydrgesterone 10 mg( tab)/12hs/14 days and montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2018to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS high responders high numbers of ovum retrieved
Who cannot join
- hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Banha University- Hawaa Fertility center
Banhā, Qalyubia Governorate, 13512
About this study
Official title: Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles
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.
Read the 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.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- dydrgesterone 10 mg( tab)/12hs/14 days, montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
- Keywords
- ovarian hyperstimulation syndrome, Montelukast
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dydrgesterone 10 mg( tab)/12hs/14 daysDrug
Also called progesterone only
Dydrogesterone Oral Tablet 10 mg twice daily for 14 days to be taken from the day of ovum pickup
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 group | Role | What they receive |
|---|---|---|
| control | Active comparator | dydrgesterone 10 mg( tab)/12hs/14 days Receives: 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 Receives: Combination Product: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who develop ovarian hyperstimulation syndrome
incidence
Measured: 0-14 days
Secondary outcomes (1)
Number of Participants treated of ovarian hyperstimulation syndrome
treatment \& resolution
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start5 Dec 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: no fund
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaa Fertility Center
- Responsible party
- Principal investigator, Ahmed Saad, Benha University
- Investigators
- ahmed sa saad, MD, ph D, Principal investigator, Hawaa Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794037
- Sponsor's protocol ID
- Hawaa-5
- Status last verified
- Sep 2022
- First submitted
- 2 Jan 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol, results,statistics
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles
- ClinicalTrials.gov ID
- NCT03794037
- Acronym / sponsor ID
- Hawaa-5
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- ovarian hyperstimulation syndrome, Montelukast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: no fund
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Hawaa Fertility Center
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: dydrgesterone 10 mg( tab)/12hs/14 daysdydrgesterone 10 mg( tab)/12hs/14 days |
| study | Experimental | Combination Product: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 daysmontelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- PCOS high responders high numbers of ovum retrieved
Key exclusion criteria (1 listed)
- hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dydrgesterone 10 mg( tab)/12hs/14 daysAlso: progesterone onlyDydrogesterone Oral Tablet 10 mg twice daily for 14 days to be taken from the day of ovum pickup | Drug | control |
| montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 daysmontelukast 10 mg(tab) once daily oral for 7 days \& dydrgesterone 10 mg (tab) twice daily oral for 14 days \& | Combination product | study |
Primary outcome
Number of Participants who develop ovarian hyperstimulation syndrome
Time frame: 0-14 days
incidence
1 secondary outcome
Number of Participants treated of ovarian hyperstimulation syndrome
Time frame: 0-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Yes. study protocol, results,statistics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed sa saad, MD, ph D principal investigator
Hawaa Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dydrgesterone 10 mg( tab)/12hs/14 days and montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days in people with Ovarian Hyperstimulation Syndrome, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who develop ovarian hyperstimulation syndrome (time frame: 0-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.