Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Benha University
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Occurrence of ovarian hyperstimuation syndrome
Study Overview
Brief Summary
Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian hyperstimulation syndrome in context of assisted reproductive technologies aiming in its prevention
Detailed Description
Women undergoing in vitro fertilization or intracytoplasmic sperm injection whom were at high risk for developing ovarian hyperstimuation syndrome were received either oral Cabergoline.5mg tablets for 7days starting on ovum pick up day and continued for 7days or received 10ml of 10%calcium gluconate in 200ml normal saline on ovum pick up day and continued for 4days
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •women undergoing assisted reproductive technologies whom at high risk for developing ovarian hyperstimulation syndrome as with high basal antimullerian hormone ,excess antral follicular count ,high seum estradiol on day of humian choronic gonadotrophin
Exclusion Criteria
- •women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes
Arms & Interventions
Calcium infusion
10ml 10%calcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days
Intervention: Calcium Gluconate (Drug)
Oral Cabergoline
Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily
Intervention: Oral Cabergoline (Drug)
Outcomes
Primary Outcomes
Occurrence of ovarian hyperstimuation syndrome
Time Frame: 20 days from ovum pick up day
Clinical condition occurred in context of assisted reproductive technologies in which there serous sacs fluid accumulation and hemoconcentration
Secondary Outcomes
- Chemical pregnancy(14 day from embryos transfer day)
- Types of ovarian hyperstimuation syndrome and severity(20 days from ovum pick up day)
- Clinical pregnancy(5 week from embryos transfer day)
Investigators
ashraf nassif mahmoud elmantwe,MD
Assistant professor
Benha University