Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

NCT ID: NCT03473613

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2017-04-15

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

Conditions

Ovarian Hyperstimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Calcium Gluconate

Intervention Type: DRUG

Giving 10 ml of 10 % calcium gluconate on 200 ml normal saline solution o.9% intravenously over thirty minutes starting on ovum pick up day and continued for four days

Oral Cabergoline

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

Group Type: ACTIVE_COMPARATOR

Oral Cabergoline

Intervention Type: DRUG

Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days

Interventions

Oral Cabergoline

Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days

Intervention Type: DRUG

Calcium Gluconate

Giving 10 ml of 10 % calcium gluconate on 200 ml normal saline solution o.9% intravenously over thirty minutes starting on ovum pick up day and continued for four days

Intervention Type: DRUG

Other Intervention Names

Cabergamon; Calcium

Eligibility 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

ashraf nassif mahmoud elmantwe,MD

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashraf N Elmantwe, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

Ashraf nassif Elmantwe

Cairo, Elqalopia, Egypt

Countries

Egypt

Other Identifiers

Ashraf Elmantwe 1

Identifier Type: -

Identifier Source: org_study_id