Calcium for Prevention of Ovarian Hyperstimulation Syndrome

NCT01427335 — Phase 3, Completed, 200 participants, Cairo University

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

Registry	NCT01427335, acronym OHSS
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, prevention
Enrollment	200 (Actual)
Sponsor	Cairo University (Other)
Conditions	Ovarian Hyperstimulation Syndrome
Interventions	calcium, 0.9 % saline (Drug)
Dates	start 2011-10-01, primary completion 2013-09-01, completion 2013-09-01, first posted 2011-09-01, last updated 2014-07-09
Locations	1 site in Egypt

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
saline	Placebo comparator	Drug: 0.9 % saline	0.9% saline intravenous infusion
calcium	Experimental	Drug: calcium	Calcium intravenous infusion

calcium (Drug), also known as Calcium intravenous infsuion: 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 (Drug): 0.9 % saline intravenous infusion

+Outcome measures

Primary outcomes

OHSS rate [2 years]: ovarain hyperstimulation syndrome

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 20 Years to 38 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Kasr elini hospital	Cairo, Cario	Egypt

+Publications

Results publication: El-Khayat W, Elsadek M. Calcium infusion for the prevention of ovarian hyperstimulation syndrome: a double-blind randomized controlled trial. Fertil Steril. 2015 Jan;103(1):101-5. doi: 10.1016/j.fertnstert.2014.09.046. PMID 25552412

+Investigators

Waleed M El-Khayat, M.D., Principal investigator, Cairo University