Calcium for Prevention of Ovarian Hyperstimulation Syndrome

Phase 3

Completed

• Conditions: Ovarian Hyperstimulation Syndrome
• Interventions: Drug: 0.9 % saline; Drug: calcium

• Registration Number: NCT01427335
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Study Start: 2011-10
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	0.9 % saline	0.9% saline intravenous infusion
calcium	calcium	Calcium intravenous infusion

Primary Outcome Measures

Name	Time	Method
OHSS rate	2 years	ovarain hyperstimulation syndrome

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	2 years	positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age

Trial Locations

Locations (1)

Kasr elini hospital; 🇪🇬 Cairo, Cario, Egypt