NCT07043322 Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
| NCT ID | NCT07043322 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tanta University |
| Condition | Gynecologic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2026-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2025-06-30 with a primary completion date of 2026-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication of controlled ovarian stimulation of gonadotrophin-Stimulated ovarian cycles. It is theorized to manifest systemically as a result of vasoactive mediators like vascular endothelium growth factor (VEGF) being released from hyperstimulated ovaries. As a result, capillary permeability is increased which causes the extravasation of fluid from the intravascular compartment into the third space. The haemoconcentration which ensues results in complications such as hypercoagulability and reduced end organ perfusion.
Eligibility Criteria
Inclusion Criteria: * Age between 18-38 years * Body mass index (calculated as weight in kilograms divided by the square of height in meters) \< 30 kg/m2. * A long luteal protocol is used for ovarian stimulation. * Day 2 FSH \<10 mIU/L and E2\< 50 pg/ml * High risk of OHSS, defined as having more than 20 follicles \>12 mm in diameter and/or E2 levels \> 3000 pg/ml when the size of the leading follicle is \> 15 mm Exclusion Criteria: The presence of chronic medical diseases, including liver cell failure, renal failure, uncontrolled hypertension, uncontrolled diabetes mellitus, or class 3 or 4 function heart disease in the New York heart association classification. Allergy to Cabergoline.
Frequently Asked Questions
Who can join the NCT07043322 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 35 Years, studying Gynecologic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07043322 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07043322 currently recruiting?
Yes, NCT07043322 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tanta University to inquire about joining.
Where is the NCT07043322 trial being conducted?
This trial is being conducted at Damietta, Egypt.
Who is sponsoring the NCT07043322 clinical trial?
NCT07043322 is sponsored by Tanta University. The trial plans to enroll 150 participants.