Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Benha University

Status and phase: Completed; Phase 3

Conditions: Ovarian Hyperstimulation

Treatments: Drug: Oral Cabergoline; Drug: Calcium Gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT03473613

Ashraf Elmantwe 1

Details and patient eligibility

About

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

Full 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

Enrollment: 230 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Calcium infusion

Active Comparator group

Description:

10ml 10%calcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days

Treatment:

Drug: Calcium Gluconate

Oral Cabergoline

Active Comparator group

Description:

Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily

Treatment:

Drug: Oral Cabergoline