Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome
1 other identifier
interventional
170
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 27, 2018
December 1, 2018
1.8 years
August 18, 2016
December 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Moderate or severe ovarian hyperstimulation syndrome
Within 4 weeks of HCG adminstration
Secondary Outcomes (1)
The Number of Participants Who Achieved Ongoing Pregnancy
18 weeks after embryo transfer
Study Arms (2)
Cabergoline group
ACTIVE COMPARATORCabergoline is administered starting on the day of HCG administration.
Calcium gluconate infusion group
EXPERIMENTALCalcium gluconate is administered starting on the day of HCG administration.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Patients who are stimulated using the long luteal GnRH agonist protocol and at high risk for developing OHSS \[have more than 18 follicles (\> 11mm) and serum estradiol ≥ 3000 pg/ml on the day of HCG administration\].
You may not qualify if:
- Fibrosis of lung
- Swelling or inflammation around the heart or lung
- Hypertension
- Liver disease
- Heart valve disease and allergy to cabergoline or ergot derivatives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aljazeera hospital
Giza, Egypt
Riyadh Fertility and Reproductive Health center
Giza, Egypt
Related Publications (1)
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.
PMID: 21621772BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Usama M Fouda, M.D,PhD
Aljazeera( Al Gazeera) hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D, PhD
Study Record Dates
First Submitted
August 18, 2016
First Posted
August 23, 2016
Study Start
October 1, 2016
Primary Completion
August 1, 2018
Study Completion
December 1, 2018
Last Updated
December 27, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share