Ovarian Hyperstimulation Syndrome Using Calcium Infusion

Al-Azhar University

Status: Unknown

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: 0.9 % saline; Drug: Calcium intravenous infsuion

Study type: Interventional

Funder types: Other

Identifiers

NCT05198128

2217-2021

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Calcium intravenous infusion

Experimental group

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

Treatment:

Drug: Calcium intravenous infsuion

saline

Placebo Comparator group

Description:

0.9 % saline intravenous infusion

Treatment:

Drug: 0.9 % saline