Back to resultsCabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome
Primary Purpose
OHSS
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cabergoline
Calcium gluconate
Sponsored by
About this trial
This is an interventional prevention trial for OHSS focused on measuring OHSS, Infertility, Cabergoline, Calcium gluconate, IVF-ET
Eligibility Criteria
Inclusion Criteria:
- Patients who are stimulated using the long luteal GnRH agonist protocol and at high risk for developing OHSS [have more than 18 follicles (> 11mm) and serum estradiol ≥ 3000 pg/ml on the day of HCG administration].
Exclusion Criteria:
- Fibrosis of lung
- Swelling or inflammation around the heart or lung
- Hypertension
- Liver disease
- Heart valve disease and allergy to cabergoline or ergot derivatives.
Sites / Locations
- Aljazeera hospital
- Riyadh Fertility and Reproductive Health center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cabergoline group
Calcium gluconate infusion group
Arm Description
Cabergoline is administered starting on the day of HCG administration.
Calcium gluconate is administered starting on the day of HCG administration.
Outcomes
Primary Outcome Measures
Moderate or severe ovarian hyperstimulation syndrome
Secondary Outcome Measures
The Number of Participants Who Achieved Ongoing Pregnancy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02875587
Brief Title
Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome
Official Title
Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aljazeera Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS.
Detailed Description
Ovarian hyperstimulation syndrome (OHSS) is a serious complication of assisted reproduction.
Previous studies revealed that calcium gluconate infusion reduced the risk of OHSS. Other studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was effective in preventing OHSS.
The aim of this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OHSS
Keywords
OHSS, Infertility, Cabergoline, Calcium gluconate, IVF-ET
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabergoline group
Arm Type
Active Comparator
Arm Description
Cabergoline is administered starting on the day of HCG administration.
Arm Title
Calcium gluconate infusion group
Arm Type
Experimental
Arm Description
Calcium gluconate is administered starting on the day of HCG administration.
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Intervention Description
Cabergoline (Dostinex; Pfizer, Italy) at a daily dose of 0.5 mg is administered orally at bed time for 8 days starting on the day of HCG administration
Intervention Type
Drug
Intervention Name(s)
Calcium gluconate
Intervention Description
Intravenous 10% calcium gluconate, 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1, day 2, and day 3 after ovum pickup. Intravenous infusion will be performed within 30 minutes.
Primary Outcome Measure Information:
Title
Moderate or severe ovarian hyperstimulation syndrome
Time Frame
Within 4 weeks of HCG adminstration
Secondary Outcome Measure Information:
Title
The Number of Participants Who Achieved Ongoing Pregnancy
Time Frame
18 weeks after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are stimulated using the long luteal GnRH agonist protocol and at high risk for developing OHSS [have more than 18 follicles (> 11mm) and serum estradiol ≥ 3000 pg/ml on the day of HCG administration].
Exclusion Criteria:
Fibrosis of lung
Swelling or inflammation around the heart or lung
Hypertension
Liver disease
Heart valve disease and allergy to cabergoline or ergot derivatives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, M.D,PhD
Organizational Affiliation
Aljazeera( Al Gazeera) hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aljazeera hospital
City
Giza
Country
Egypt
Facility Name
Riyadh Fertility and Reproductive Health center
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21621772
Citation
Gurgan T, Demirol A, Guven S, Benkhalifa M, Girgin B, Li TC. Intravenous calcium infusion as a novel preventive therapy of ovarian hyperstimulation syndrome for patients with polycystic ovarian syndrome. Fertil Steril. 2011 Jul;96(1):53-7. doi: 10.1016/j.fertnstert.2011.04.094. Epub 2011 May 31.
Results Reference
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Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome
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