NCT01427335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

1.9 years

First QC Date

August 31, 2011

Last Update Submit

July 8, 2014

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

OHSSICSIcalcium injection

Outcome Measures

Primary Outcomes (1)

  • OHSS rate

    ovarain hyperstimulation syndrome

    2 years

Secondary Outcomes (1)

  • clinical pregnancy rate

    2 years

Study Arms (2)

saline

PLACEBO COMPARATOR

0.9% saline intravenous infusion

Drug: 0.9 % saline

calcium

EXPERIMENTAL

Calcium intravenous infusion

Drug: calcium

Interventions

calciumDRUG

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

Also known as: Calcium intravenous infsuion
calcium
0.9 % salineDRUG

0.9 % saline intravenous infusion

saline

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr elini hospital

Cairo, Cario, 12211, Egypt

Location

Related Publications (1)

  • 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: 25552412DERIVED

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

CalciumSodium Chloride

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Waleed M El-Khayat, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 1, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

EG(1)