Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Phase 3

Completed

• Conditions: Ovarian Hyperstimulation
• Interventions: Drug: Oral Cabergoline; Drug: Calcium Gluconate

• Registration Number: NCT03473613
• Lead Sponsor: Benha University

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 Timeline

• Study Start: 2014-10-01
• Primary Completion: 2017-04-15
• Study Completion: 2017-04-15
• Study First Submitted: 2018-02-22
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-22
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Cabergoline	Oral Cabergoline	Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily
Calcium infusion	Calcium Gluconate	10ml 10%calcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days

Primary Outcome Measures

Name	Time	Method
Occurrence of ovarian hyperstimuation syndrome	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 Outcome Measures

Name	Time	Method
Chemical pregnancy	14 day from embryos transfer day	Positive human chorionic Gonadotropin in blood
Types of ovarian hyperstimuation syndrome and severity	20 days from ovum pick up day	Clinical severity either mild ,moderate or severe and its type either early or late onst
Clinical pregnancy	5 week from embryos transfer day	Intrauterine gestational sac

Trial Locations

Locations (1)

Ashraf nassif Elmantwe; 🇪🇬 Cairo, Elqalopia, Egypt