Ovarian hyperstimulation syndrome (OHSS) is the most serious and potentially life‐threatening iatrogenic complication associated with ovarian stimulation during Assisted Reproductive Technology (ART) protocols. OHSS typically is a result of ovarian expression of vascular endothelial growth factor (VEGF) which increases vascular permeability . Objective: Effects of calcium in the prevention of ovarian hyperstimulation syndrome in patients undergoing IVF/ICSI.
Materials and Methods: 95 high risk infertile women in ivf cycle for OHSS (more than 20 follicles in both ovaries during oocyte retrieval) were randomly divided into two groups. Control group: including 93 women received ./5 mg/day dopamine agonist (cabergoline) twice aday at day of HCG injection till 5 days. Intervention group: including 93 women received ./5mg/day dopamine agonist (cabergoline) twice aday at day of HCG injection till 5 days and intravenous infusion of 10 mL 10% calcium gluconate in 200 mL 0.9% saline solution on the day of ovum pick-up (OPU) and days 1, 2, and 3 after that. The dosage of hMG used, total number of follicles developed, number of oocytes retrieved, serum E2 concentrations during the luteal phase, development of ascites, number of embryos generated clinical pregnancy rate, results of the IVF-ET cycles and incidence and severity of any OHSS were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071428930N1
Registration date:2017-01-05, 1395/10/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-05, 1395/10/16
Registrant information
Name
Maliha Mahmoudinia
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9878
Email address
mahmoudiniam941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor Of Research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-04-01, 1395/01/13
Expected recruitment end date
2017-04-02, 1396/01/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Infusion of calcium gluconate for Prevention of Ovarian Hyperstimulation Syndrome in IVF cycle
Public title
Effects of calcium in the prevention of ovarian hyperstimulation syndrome in patients undergoing IVF/ICSI
Purpose
Prevention
Inclusion/Exclusion criteria
Patients at high risk of ovarian hyperstimulation :
PCO; patients having more than 20 follicles> 12 mm during oocyte retrieval;
History of OHSS in previous cycles;Estradiol levels over 2500 on the day of HCG administration.
Exclusion criteria: Diabetes ; Hypertension ;Asthma ;Blood pressure and Heart disease.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
186
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
Vice Chancellor Of Research, Mashhad University of Medical Sciences, Mashhad University of Medical Sciences,University Avenue, Mashhad
City
Mashhad
Postal code
Approval date
2016-09-03, 1395/06/13
Ethics committee reference number
IR.MUMS.REC.1395.326
Health conditions studied
1
Description of health condition studied
ovarian hyperstimulation
ICD-10 code
N98.1
ICD-10 code description
Hyperstimulation of ovaries
Primary outcomes
1
Description
Prevention of OHSS
Timepoint
From strat to 2 weaks later
Method of measurement
Clinical signs and sonography Transvaginal
Secondary outcomes
1
Description
Severity of OHSS
Timepoint
From start to 15 days later
Method of measurement
Clinical signs and Transvaginal sonography
Intervention groups
1
Description
High risk infertile women in ivf cycle for OHSS (more than 20 follicles in both ovaries during oocyte retrieval) were randomly divided into two groups.control group received ./5mg/day dopamine agonist (cabergolin) twice aday at day of HCG injection untill 5 days
Category
Treatment - Drugs
2
Description
Intervention group received ./5mg/day dopamine agonist (cabergolin) twice aday at day of HCG injection till 5 days and intravenous infusion of 10 mL 10% calcium gluconate in 200 mL 0.9% saline solution on the day of ovum pick-up (OPU) and days 1, 2, and 3 after that.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility Center
Full name of responsible person
Malihh Mahmoudinia
Street address
Milad Infertility center, Mashhad, Khorasan Razavi
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Mashhad University of Medical Sciences
Full name of responsible person
Ardakanian
Street address
Vice Chancellor Of Research,Mashhad University of Medical Sciences ,Mashhad University of Medical Sciences,University Avenue ,Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Nayyereh khadem
Position
professor of gynecology group
Other areas of specialty/work
Street address
Emam Reza Hospital ,Mashhad, Khorasan Razavi
City
Mashhad
Postal code
Phone
+98 51 3801 2607
Fax
Email
khademn@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Nayyereh khadem
Position
Professor of Gynecology
Other areas of specialty/work
Street address
Emam Reza Hospital, Mashhad, Khorasan Razavi
City
Mashhad
Postal code
Phone
+98 51 3801 2607
Fax
Email
khademn@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihh Mahmoudinia
Position
Fellowship Of Infertility
Other areas of specialty/work
Street address
Milad Hospital ,Mashhad ,khorasan Razavi
City
Mashhad
Postal code
Phone
+98 51 3853 4021
Fax
Email
mahmoudiniam941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)