Calcium for Prevention of Ovarian Hyperstimulation Syndrome

Ovarian Hyperstimulation Syndrome Clinical Trial

— OHSS  

Official title:

Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427335
• Other study ID #: 192011
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2011
• Last updated: July 8, 2014
• Start date: October 2011
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome

Intervention

Drug:
• calcium
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
0.9 % saline intravenous infusion

Locations

Country	Name	City	State
Egypt	Kasr elini hospital	Cairo	Cario

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OHSS rate	ovarain hyperstimulation syndrome	2 years	Yes
Secondary	clinical pregnancy rate	positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age	2 years	No