Cabergoline plus coasting to reduce ovarian hyperstimulation syndrome
Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
PHASE2 · Tanta University · NCT07043322
This test checks whether adding cabergoline to coasting lowers the chance of ovarian hyperstimulation syndrome in women at high risk during gonadotropin ovarian stimulation.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Damietta, New Damietta) |
| Trial ID | NCT07043322 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study enrolls women at high risk for OHSS who are undergoing controlled ovarian stimulation with a long luteal protocol. Participants will undergo standard coasting and some will also receive cabergoline, with clinicians monitoring follicle growth, estradiol levels, and clinical signs of OHSS. The main outcome is the incidence and severity of OHSS, with safety and adverse events tracked throughout stimulation and the peri-trigger period. The protocol excludes patients with major uncontrolled medical conditions or known allergy to cabergoline.
Who should consider this trial
Good fit: Women aged 18–38 with BMI under 30 using a long luteal gonadotropin stimulation protocol who meet high-risk criteria for OHSS (more than 20 follicles >12 mm and/or estradiol >3000 pg/ml when the leading follicle is >15 mm) and have Day 2 FSH <10 mIU/L and E2 <50 pg/ml.
Not a fit: Patients with uncontrolled chronic diseases (severe liver, kidney, cardiac disease, uncontrolled hypertension or diabetes), known allergy to cabergoline, BMI ≥30, or outside the 18–38 age range are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this approach could reduce the risk and severity of OHSS, lowering complications and the need for hospitalization during fertility treatment.
How similar studies have performed: Previous studies have shown cabergoline can modestly reduce OHSS risk and coasting is an established prevention method, so combining them has some supportive but not definitive evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Damietta, New Damietta
- Mostafa Bahaa — Damietta, New Damietta, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gynecologic Disease