Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome. A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Aljazeera Hospital
- Enrollment
- 170
- Locations
- 2
- Primary Endpoint
- Moderate or severe ovarian hyperstimulation syndrome
Study Overview
Brief Summary
The aim of this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS.
Detailed Description
Ovarian hyperstimulation syndrome (OHSS) is a serious complication of assisted reproduction.
Previous studies revealed that calcium gluconate infusion reduced the risk of OHSS. Other studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was effective in preventing OHSS.
The aim of this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 37 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are stimulated using the long luteal GnRH agonist protocol and at high risk for developing OHSS [have more than 18 follicles (> 11mm) and serum estradiol ≥ 3000 pg/ml on the day of HCG administration].
Exclusion Criteria
- •Fibrosis of lung
- •Swelling or inflammation around the heart or lung
- •Hypertension
- •Liver disease
- •Heart valve disease and allergy to cabergoline or ergot derivatives.
Arms & Interventions
Cabergoline group
Cabergoline is administered starting on the day of HCG administration.
Intervention: Cabergoline (Drug)
Calcium gluconate infusion group
Calcium gluconate is administered starting on the day of HCG administration.
Intervention: Calcium gluconate (Drug)
Outcomes
Primary Outcomes
Moderate or severe ovarian hyperstimulation syndrome
Time Frame: Within 4 weeks of HCG adminstration
Secondary Outcomes
- The Number of Participants Who Achieved Ongoing Pregnancy(18 weeks after embryo transfer)
Investigators
Prof .Usama M.Fouda
M.D, PhD
Aljazeera Hospital