Ovarian Hyper Stimulation Syndrome (OHSS)OHSSNCT06739759
Ovarian Hyperstimulation Syndrome Prevention
A study testing Antagonist protocol for IVF and Modified Agonist protocol for IVF with additive treatments as HCQ in people with Ovarian Hyper Stimulation Syndrome (OHSS), run by Aljazeera Hospital at 2 sites in Egypt.
Trial summary
Ovarian hyperstimulation is a very hazardous complication of ICSI Read more about this study
- Who is it for?
- Ages 19 to 42 years, women only
- Conditions the study is for
- Ovarian Hyper Stimulation Syndrome (OHSS)
- What is being tested?
- Antagonist protocol for IVF and Modified Agonist protocol for IVF with additive treatments as HCQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesEgypt
- Study dates
- 17 Nov 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with PCOS coming for ICSI
Who cannot join
- Women who donnot have PCOS
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Aljazeerah hospital
Giza, 12345
Mahmoud Alalfy, MD, 01002611058, mahmoudalalfy@ymail.com
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Prophylaxis Against Ovarian Hyperstimulation Syndrome in PCOS Women
Ovarian hyperstimulation is a very hazardous complication of ICSI
Read the detailed description
Ovarian hyperstimulation could be mild , moderate , severe or marked
- Being tested
- Antagonist protocol for IVF, Modified Agonist protocol for IVF with additive treatments as HCQ
- Keywords
- OHSS, mild, Moderate, Severe
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antagonist protocol for IVFDrug
Also called Antagonist
antagonist protocol with triggering by Decapeptyl
Modified Agonist protocol for IVF with additive treatments as HCQDrug
Also called modified agonist with additives
giving additive drugs to agonist protocolas HCQ
| Study group | Role | What they receive |
|---|---|---|
| antagonist | Active comparator | patients with PCOS undergoing ICSI receiving antagonist protocol Receives: Drug: Antagonist protocol for IVF |
| Modified agonist with additives | Active comparator | Patients with PCOS undergoing ICSI receiving modified agonist protocol with additives Receives: Drug: Modified Agonist protocol for IVF with additive treatments as HCQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of OHSS
prevention of symptoms of ovarian hyperstimulation syndrome as amount of ascites in litres by US
Measured: within 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start17 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyper Stimulation Syndrome (OHSS)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, MD, Study chair, Aljazeera Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739759
- Sponsor's protocol ID
- ovarian hyperstimulation
- Acronym
- OHSS
- Status last verified
- Dec 2024
- First submitted
- 23 Oct 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis Against Ovarian Hyperstimulation Syndrome in PCOS Women
- ClinicalTrials.gov ID
- NCT06739759
- Acronym / sponsor ID
- OHSS / ovarian hyperstimulation
- Keywords
- OHSS, mild, Moderate, Severe
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 18 Dec 2024 (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.
Ovarian hyperstimulation is a very hazardous complication of ICSI
Detailed description
Ovarian hyperstimulation could be mild , moderate , severe or marked
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antagonist | Active comparator | Drug: Antagonist protocol for IVFpatients with PCOS undergoing ICSI receiving antagonist protocol |
| Modified agonist with additives | Active comparator | Drug: Modified Agonist protocol for IVF with additive treatments as HCQPatients with PCOS undergoing ICSI receiving modified agonist protocol with additives |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with PCOS coming for ICSI
Key exclusion criteria (1 listed)
- Women who donnot have PCOS
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 |
|---|---|---|
| Antagonist protocol for IVFAlso: Antagonistantagonist protocol with triggering by Decapeptyl | Drug | antagonist |
| Modified Agonist protocol for IVF with additive treatments as HCQAlso: modified agonist with additivesgiving additive drugs to agonist protocolas HCQ | Drug | Modified agonist with additives |
Primary outcome
prevention of OHSS
Time frame: within 3 weeks
prevention of symptoms of ovarian hyperstimulation syndrome as amount of ascites in litres by US
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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.
Mahmoud Alalfy, MD study chair
Aljazeera Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antagonist protocol for IVF and Modified Agonist protocol for IVF with additive treatments as HCQ in people with Ovarian Hyper Stimulation Syndrome (OHSS), run by Aljazeera Hospital at 2 sites 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alalfy, MD (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of OHSS (time frame: within 3 weeks). 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 18 Dec 2024.