Calcium for Prevention of Ovarian Hyperstimulation Syndrome

Cairo University200 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

200

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

calciumDRUG

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 % salineDRUG

0.9 % saline intravenous infusion

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 38 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Kasr elini hospital

Cairo, Cario, Egypt

Outcomes

Primary Outcomes

OHSS rate

ovarain hyperstimulation syndrome

Time frame: 2 years

Secondary Outcomes

clinical pregnancy rate

positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.