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Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)

This study is currently recruiting participants.
Verified November 2011 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01427335
First received: August 31, 2011
Last updated: December 27, 2011
Last verified: November 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Calcium
U.S. FDA Resources

Further study details as provided by Cairo University:

Primary Outcome Measures:
  • OHSS rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    ovarain hyperstimulation syndrome


Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age


Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 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

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427335

Contacts
Contact: Waleed M El-Khayat, M.D. 0105135542 ext +2 waleed_elkhyat@yahoo.com

Locations
Egypt
Kasr elini hospital Recruiting
Cairo, Cario, Egypt, 12211
Contact: Waleed M El-Khayat, M.D.     0105135542 ext +2     waleed_elkhyat@yahoo.com    
Principal Investigator: Waleed M El-Khayat, M.D.            
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Waleed M El-Khayat, M.D. Cairo University
  More Information

No publications provided

Responsible Party: Waleed El-khayat, Doctor, Cairo University
ClinicalTrials.gov Identifier: NCT01427335     History of Changes
Other Study ID Numbers: 192011
Study First Received: August 31, 2011
Last Updated: December 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cairo University:
OHSS
ICSI
calcium injection

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
 Endocrine System Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013