Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Ovarian Hyperstimulation Clinical Trial

Official title:

Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03473613
• Other study ID #: Ashraf Elmantwe 1
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2018
• Last updated: March 27, 2018
• Start date: October 1, 2014
• Est. completion date: April 15, 2017

Study information

• Verified date: March 2018
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: April 15, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Hyperstimulation
• Ovarian Hyperstimulation Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Ashraf nassif Elmantwe	Cairo	Elqalopia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of ovarian hyperstimuation syndrome	Clinical condition occurred in context of assisted reproductive technologies in which there serous sacs fluid accumulation and hemoconcentration	20 days from ovum pick up day
Secondary	Types of ovarian hyperstimuation syndrome and severity	Clinical severity either mild ,moderate or severe and its type either early or late onst	20 days from ovum pick up day
Secondary	Chemical pregnancy	Positive human chorionic Gonadotropin in blood	14 day from embryos transfer day
Secondary	Clinical pregnancy	Intrauterine gestational sac	5 week from embryos transfer day