Back to resultsCabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention
Primary Purpose
Ovarian Hyperstimulation
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Oral Cabergoline
Calcium Gluconate
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Hyperstimulation focused on measuring Calcium infusion, Cabergoline
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:women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes
-
Sites / Locations
- Ashraf nassif Elmantwe
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Calcium infusion
Oral Cabergoline
Arm Description
10ml 10%calcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days
Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily
Outcomes
Primary Outcome Measures
Occurrence of ovarian hyperstimuation syndrome
Clinical condition occurred in context of assisted reproductive technologies in which there serous sacs fluid accumulation and hemoconcentration
Secondary Outcome Measures
Types of ovarian hyperstimuation syndrome and severity
Clinical severity either mild ,moderate or severe and its type either early or late onst
Chemical pregnancy
Positive human chorionic Gonadotropin in blood
Clinical pregnancy
Intrauterine gestational sac
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03473613
Brief Title
Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention
Official Title
Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
April 15, 2017 (Actual)
Study Completion Date
April 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation
Keywords
Calcium infusion, Cabergoline
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcium infusion
Arm Type
Active Comparator
Arm Description
10ml 10%calcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days
Arm Title
Oral Cabergoline
Arm Type
Active Comparator
Arm Description
Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily
Intervention Type
Drug
Intervention Name(s)
Oral Cabergoline
Other Intervention Name(s)
Cabergamon
Intervention Description
Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days
Intervention Type
Drug
Intervention Name(s)
Calcium Gluconate
Other Intervention Name(s)
Calcium
Intervention Description
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
Primary Outcome Measure Information:
Title
Occurrence of ovarian hyperstimuation syndrome
Description
Clinical condition occurred in context of assisted reproductive technologies in which there serous sacs fluid accumulation and hemoconcentration
Time Frame
20 days from ovum pick up day
Secondary Outcome Measure Information:
Title
Types of ovarian hyperstimuation syndrome and severity
Description
Clinical severity either mild ,moderate or severe and its type either early or late onst
Time Frame
20 days from ovum pick up day
Title
Chemical pregnancy
Description
Positive human chorionic Gonadotropin in blood
Time Frame
14 day from embryos transfer day
Title
Clinical pregnancy
Description
Intrauterine gestational sac
Time Frame
5 week from embryos transfer day
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women undergoing assisted reproductive technologies
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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:women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf N Elmantwe, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashraf nassif Elmantwe
City
Cairo
State/Province
Elqalopia
ZIP/Postal Code
5131
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Contact investigators
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Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention
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