Calcium for Prevention of Ovarian Hyperstimulation Syndrome

NCT ID: NCT01427335

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-09-30

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.

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

Conditions

Ovarian Hyperstimulation Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

saline

0.9% saline intravenous infusion

Group Type: PLACEBO_COMPARATOR

0.9 % saline

Intervention Type: DRUG

0.9 % saline intravenous infusion

calcium

Calcium intravenous infusion

Group Type: EXPERIMENTAL

calcium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

0.9 % saline

0.9 % saline intravenous infusion

Intervention Type: DRUG

Other Intervention Names

Calcium intravenous infsuion

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Waleed El-khayat

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waleed M El-Khayat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr elini hospital

Cairo, Cario, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 25552412 (View on PubMed)

Other Identifiers

192011

Identifier Type: -

Identifier Source: org_study_id