Back to resultsCalcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)
Primary Purpose
Ovarian Hyperstimulation Syndrome
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
calcium
0.9 % saline
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring OHSS, ICSI, calcium injection
Eligibility Criteria
Inclusion Criteria:
- infertile women aged 20 to 38 years.
- BMI ranged from 18 to 40.
- serum FSH within normal limits( 1-12IU /l)
- presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.
Exclusion Criteria:
- endocrinopathies.
- a systemic disease.
- using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists.
- patients need coasting for high risk of OHSS.
- patients need cycle cancellation.
- severe male infertility requiring testicular sperm extraction.
Sites / Locations
- Kasr elini hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
saline
calcium
Arm Description
0.9% saline intravenous infusion
Calcium intravenous infusion
Outcomes
Primary Outcome Measures
OHSS rate
ovarain hyperstimulation syndrome
Secondary Outcome Measures
clinical pregnancy rate
positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01427335
Brief Title
Calcium for Prevention of Ovarian Hyperstimulation Syndrome
Acronym
OHSS
Official Title
Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
OHSS, ICSI, calcium injection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
0.9% saline intravenous infusion
Arm Title
calcium
Arm Type
Experimental
Arm Description
Calcium intravenous infusion
Intervention Type
Drug
Intervention Name(s)
calcium
Other Intervention Name(s)
Calcium intravenous infsuion
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
0.9 % saline
Intervention Description
0.9 % saline intravenous infusion
Primary Outcome Measure Information:
Title
OHSS rate
Description
ovarain hyperstimulation syndrome
Time Frame
2 years
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
infertile women aged 20 to 38 years.
BMI ranged from 18 to 40.
serum FSH within normal limits( 1-12IU /l)
presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.
Exclusion Criteria:
endocrinopathies.
a systemic disease.
using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists.
patients need coasting for high risk of OHSS.
patients need cycle cancellation.
severe male infertility requiring testicular sperm extraction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed M El-Khayat, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr elini hospital
City
Cairo
State/Province
Cario
ZIP/Postal Code
12211
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
25552412
Citation
El-Khayat W, Elsadek M. Calcium infusion for the prevention of ovarian hyperstimulation syndrome: a double-blind randomized controlled trial. Fertil Steril. 2015 Jan;103(1):101-5. doi: 10.1016/j.fertnstert.2014.09.046.
Results Reference
derived
Learn more about this trial
Calcium for Prevention of Ovarian Hyperstimulation Syndrome
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