Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)
There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS & the mechanism of its action is still questionable . In the study the investigators try to search for the evidence for its effect & the real mechanism for its action.
Ovarian Hyperstimulation Syndrome
Drug: 0.9 % saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial|
- OHSS rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]ovarain hyperstimulation syndrome
- clinical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age
|Study Start Date:||October 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: saline
0.9% saline intravenous infusion
Drug: 0.9 % saline
0.9 % saline intravenous infusion
Calcium intravenous infusion
intravenous infusion of 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 were administered in study group.
Intravenous infusion was performed within 30 minutes
Other Name: Calcium intravenous infsuion
The study population will be divided into 2groups each containing 100 infertile couples candidate for ICSI.
Group (A)active group: administration of 10% Intravenous 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 was performed within 30 minutes.
Group (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427335
|Kasr elini hospital|
|Cairo, Cario, Egypt, 12211|
|Principal Investigator:||Waleed M El-Khayat, M.D.||Cairo University|