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Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)

This study has been completed.
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University Identifier:
First received: August 31, 2011
Last updated: July 8, 2014
Last verified: July 2014
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 Intervention Phase
Ovarian Hyperstimulation Syndrome
Drug: calcium
Drug: 0.9 % saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial

Resource links provided by NLM:

Further study details as provided by Waleed El-khayat, Cairo University:

Primary Outcome Measures:
  • OHSS rate [ Time Frame: 2 years ]
    ovarain hyperstimulation syndrome

Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 2 years ]
    positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age

Enrollment: 200
Study Start Date: October 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Calcium intravenous infsuion

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


Ages Eligible for Study:   20 Years to 38 Years   (Adult)
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.

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.
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Please refer to this study by its identifier: NCT01427335

Kasr elini hospital
Cairo, Cario, Egypt, 12211
Sponsors and Collaborators
Cairo University
Principal Investigator: Waleed M El-Khayat, M.D. Cairo University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Waleed El-khayat, Doctor, Cairo University Identifier: NCT01427335     History of Changes
Other Study ID Numbers: 192011
Study First Received: August 31, 2011
Last Updated: July 8, 2014

Keywords provided by Waleed El-khayat, Cairo University:
calcium injection

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 25, 2017