OHSS: Calcium for Prevention of Ovarian Hyperstimulation Syndrome

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT01427335

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Hyperstimulation Syndrome	Drug: calcium Drug: 0.9 % saline	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: saline

0.9% saline intravenous infusion

Drug: 0.9 % saline

0.9 % saline intravenous infusion

Experimental: calcium

Calcium intravenous infusion

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

Other Names:

Calcium intravenous infsuion

Outcome Measures

Primary Outcome Measures

OHSS rate [2 years]
ovarain hyperstimulation syndrome

Secondary Outcome Measures

clinical pregnancy rate [2 years]
positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.