Ovarian Hyperstimulation Syndrome Using Calcium Infusion

Sponsor

Al-Azhar University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05198128

Collaborator

(none)

200

Enrollment

Arms

14.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

the incidence of OHSS and clinical outcomes after calcium IV infusion in high-risk women undergoing ART

Condition or Disease	Intervention/Treatment	Phase
Ovarian Hyperstimulation Syndrome	Drug: Calcium intravenous infsuion Drug: 0.9 % saline	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Ovarian Hyper Stimulation Syndrome Using Calcium Infusion

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Apr 25, 2023

Anticipated Study Completion Date :

May 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Calcium intravenous infsuion 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
Placebo Comparator: saline 0.9 % saline intravenous infusion	Drug: 0.9 % saline 0.9 % saline

Arm

Intervention/Treatment

Experimental: 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

Drug: Calcium intravenous infsuion

Placebo Comparator: saline

0.9 % saline intravenous infusion

Drug: 0.9 % saline

0.9 % saline

Outcome Measures

Primary Outcome Measures

OHSS rate [one year]
ovarain hyperstimulation syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.