Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)

July 8, 2014 updated by: Waleed El-khayat, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cario
      • Cairo, Cario, Egypt, 12211
        • Kasr elini hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OHSS rate
Time Frame: 2 years
ovarain hyperstimulation syndrome
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 2 years
positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Waleed M El-Khayat, M.D., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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