Back to resultsOvarian Hyperstimulation Syndrome Using Calcium Infusion
Primary Purpose
Ovarian Hyperstimulation Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calcium intravenous infsuion
0.9 % saline
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Hyperstimulation Syndrome focused on measuring OHSS, calcium infusion, IVF, ICSI
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. and Insulin-dependent diabetes Thyroid 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Calcium intravenous infusion
saline
Arm 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
0.9 % saline intravenous infusion
Outcomes
Primary Outcome Measures
OHSS rate
ovarain hyperstimulation syndrome
Secondary Outcome Measures
Full Information
NCT ID
NCT05198128
First Posted
December 19, 2021
Last Updated
February 20, 2022
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT05198128
Brief Title
Ovarian Hyperstimulation Syndrome Using Calcium Infusion
Official Title
Ovarian Hyper Stimulation Syndrome Using Calcium Infusion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
April 25, 2023 (Anticipated)
Study Completion Date
May 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
the incidence of OHSS and clinical outcomes after calcium IV infusion in high-risk women undergoing ART
Detailed Description
Among assisted reproductive technologies (ART), ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication affects up to 30% of women undergoing ART and caries high risks of morbidity and mortality. Women with age younger than 35 years, those with history of polycystic ovary syndrome (PCOS), or having a history of previous OHSS are more susceptible to develop OHSS
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
OHSS, calcium infusion, IVF, ICSI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Calcium intravenous infusion
Arm Type
Experimental
Arm 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
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
0.9 % saline intravenous infusion
Intervention Type
Drug
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
Primary Outcome Measure Information:
Title
OHSS rate
Description
ovarain hyperstimulation syndrome
Time Frame
one year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women undergoing Ovarian Hyperstimulation Syndrome
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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. and Insulin-dependent diabetes Thyroid 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.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
not yet
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Ovarian Hyperstimulation Syndrome Using Calcium Infusion
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