Achieving cheaper, more affordable, and safe drug therapy method with fewer side effects for managing severe ovarian hyperstimulation syndrome.
Design
Randomized controlled trial, community based and pragmatic, with parallel groups, blind, randomized
Settings and conduct
Sarem Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Severe ovarian hyperstimulation syndrome based on the classification of Rizg and Aboulghar.
Exclusion criteria: Patient's dissatisfaction with the study; occurrence/history of allergy to the drug.
Intervention groups
Intervention group: 500-mL mannitol 20% is infused with 500 mL
D5NS solution through a Y-site over 4 hours. Pulmonary auscultation, abdominal girth, renal function and hemoconcentration are monitored , after 4 hours of infusion, 500-mL D5NS was infused over 30-60 minutes. The second infusion was not performed if examinations indicated progressive fluid retention in the body.
Control group: 1 L of normal saline is initially infused over 1 hour. If the patient has an appreciable urine output (50 ml over the hour), an IV fluid "maintenance” is initiated.5% dextrose in normal saline (D5NS) 125–150 mL/h, urine output is assessed every 4 hours, and hematocrit (Hct) is determined 4 hours after the start of IV hydration to ensure that hemoconcentration is reversing. If there is inadequate response in urine output from the initial 1-L fluid bolus, an IV infusion of 250 mL of 20% albumin solution is given over 4 hours with a recheck of Hct 1 hour after the infusion. This protocol is repeated in a serial fashion (every 4 to 12 hours) until the Hct is brought within 6%–38%.
Efficacy Assessment of Mannitol vs Albumin in Management of Ovarian Hyperstimulation Syndrome – A randomized controlled trial
Public title
Mannitol efficacy in ovarian hyper stimulation syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Severe ovarian htper stimulation syndrome
Exclusion criteria:
Patient dissatisfaction to participate in the study
History of / sensitivity to the used drug
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block, individual randomization, using software; not blinded.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of medical Sciences (IUMS)
Street address
Iran University of medical Sciences (IUMS), Hemmat Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.IUMS.REC.1396.23099608825
Health conditions studied
1
Description of health condition studied
Ovarian hyper stimulation syndrome
ICD-10 code
N98.1
ICD-10 code description
Hyperstimulation of ovaries
Primary outcomes
1
Description
Abdominal girth
Timepoint
Every morning
Method of measurement
Centimeter
2
Description
Weight
Timepoint
Every morning
Method of measurement
Digital scale; kilogram
3
Description
Hematocrite
Timepoint
Every 8 to 24 hours based on clinical severity of symptoms
Method of measurement
Colormetry; Percent
4
Description
Serum creatinine
Timepoint
Every 8 to 24 hours based on clinical severity of symptoms
Method of measurement
Milligram/deciliter
5
Description
Serum sodium level
Timepoint
Every 8 to 24 hours based on clinical severity of symptoms
Method of measurement
Ion Selective Electrode (ISE); millimol/milliliter
6
Description
Serum potassium level
Timepoint
Every 8 to 24 hours based on clinical severity of symptoms
Method of measurement
Ion Selective Electrode (ISE); millimol/milliliter
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
At the end of hospitalization
Method of measurement
Number of days
2
Description
Total cost of medicine used
Timepoint
At the end of drug therapy
Method of measurement
Total cost of medicine in Rials
Intervention groups
1
Description
Intervention group: Intravenous infusion of 500 ml Mannitol 20% at the same time with 500 ml Glucose 5% using y-site over 4 hours daily or twice a day a (based on clinical responses). Intravenous solutions are the products of Shahid Ghazi (Tabriz- Iran) factories.
Category
Other
2
Description
Control group: Intravenous infusion of 100g Human Albumin (5 vials of 20% Albumin) over 4 hours, repeating every 4 ti 12 hours (based on clinical responses). Albumin vials are the product of OCTAPHARMA AG- Switzerland.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarem Specialized Hospital
Full name of responsible person
AboTaleb Saremi
Street address
Basij Sq., Phase 3, Ekbatan Town
City
Tehran
Province
Tehran
Postal code
139695111
Phone
+98 21 4467 0883
Fax
+98 21 4467 0432
Email
saremiat@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sarem Fertility and Infertility Research Center (SAFIR)
Full name of responsible person
AboTaleb Saremi
Street address
Sarem Fertility and Infertility Research Center, phase3, Ekbatan town
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Fax
+98 21 4467 0432
Email
Arashpooladi@saremcrc.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sarem Fertility and Infertility Research Center (SAFIR)
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
sarem Fertility and Infertility Research Center (SAFIR)
Full name of responsible person
Maryam Namdar Khanzedeh
Position
Head of pharmaceutical Care Department
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sarem fertility and Infertility Research Center (SAFIR), Sarem women's hospital, shahrak-e-Ekbatan, phase 3, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Fax
+98 21 4467 0432
Email
dr.m_namdar@saremcrc.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sarem Fertility and Infertility Research Center (SAFIR)
Full name of responsible person
AboTaleb Saremi
Position
Chairman of Sarem women's hospital and Sarem Fertility and Infertility Research Center (SAFIR)
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
sarem Fertility and Infertility Research Center
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Fax
+98 21 4467 0432
Email
saremiat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
sarem Fertility and Infertility Research Center (SAFIR)
Full name of responsible person
Maryam Namdar Khanzadeh
Position
Head of pharmaceutical Care Department
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sarem Fertility and Infertility Research Center (SAFIR), Sarem women's hospital, shahrak-e-Ekbatan, phase 3, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Fax
+98 21 4467 0432
Email
dr.m_namdar@saremcrc.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information on the main outcomes of the study is available for sharing.
When the data will become available and for how long
The beginning of the access period is 6 months after the publication of the results of the study.
To whom data/document is available
Official assessors of the research field of the Iran University of Medical Sciences (IUMS)
Under which criteria data/document could be used
- To verify the accuracy of the analysis of the study
- Modeling for future studies
- Use for future meta analyzes
From where data/document is obtainable
Sarem Fertility and Infertility Research Center (SAFIR)
What processes are involved for a request to access data/document
The official application to "Iran University of Medicalscience (IUMS)" will be communicated to the "Sarem Fertility and Infertility Research Center (SAFIR)" after being approved by the competent authorities. After receiving the request, SAFIR will contact the applicant within 10 days to answer the questions.