Comparing the effects of intravenous injection of calcium and hydroxyethyl starch to prevent ovarian hyperstimulation syndrome(OHSS) in high-risk women
Design
This study was done on 100 OHSS high-risk women with the age of less than 35 yrs., low weighted, polycystic ovaries (PCO) tested under ultrasound, history of OHSS and without chronic ovulation accompanied with hyperandrogenism undergone IVF and ICSI referred to infertility centers of Isfahan during 2014-15. If the patient has a history of uterine surgery, a submucosal or intramural myoma of uterus larger than 5 cm or a known kidney or liver disease or who discontinued participating in the project, she would be excluded. The patients were randomly divided into two groups and the first group was administered 100 mg normal saline with 10 mg of 10% calcium gluconate within 2 hours and it was repeated on the second and third days of oocyte removal. In the second group in a time of removing oocyte, 500cc of HES was administered by infusion and it was repeated on the second and third day of oocyte removal. Five days after embryo transfer, the sonographic examination was done for all patients in terms of OHSS findings such as the ovaries size, development of ascites and determination of OHSS intensity. Finally, patients were followed up for 3 months after receiving medications on the incidence of OHSS symptoms or pregnancy and if OHSS happened the intensity was recorded.
Settings and conduct
This study will be done at the Moshtagh infertility center and the infertility center of Shahid Beheshti hospital in Isfahan
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having OHSS high-risk
Age of less than 35 yrs.
Low weighted
polycystic ovaries (PCO) tested under ultrasound
chronic anovulation accompanied with hyperandrogenism
History of OHSS
Exclusion criteria
With history of uterine surgery
With a submucosal or intramural myoma of uterus larger than 5 cm
With a known kidney or liver disease
Refusal to cooperation in the study
Intervention groups
Injecting calcium or hydroxyethyl starch intravenously
Main outcome variables
The incidence of ovarian hyperstimulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N22
Registration date:2018-02-10, 1396/11/21
Registration timing:registered_while_recruiting
Last update:2018-02-10, 1396/11/21
Update count:0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
this study is done based on medical theses and done with financial support of research faculty of medical school of Isfahan university of medical sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Calcium infusion and Hydroxyethyl starch infusion in prevention of ovarian hyperstimulation syndrome in high risk women
Public title
Comparison effect of Calcium and Hydroxy ethyl starch injection on prevention of ovarian hyperstimulation syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
tested under transvaginal sonographic examination followed by ovulation stimulation protocols there have been more than 18 follicular with the size of more than 12 mm
patients agreement for entere to the study
Exclusion criteria:
History of uterine surgeries
existence of Sub mucusal or intra mural myoma greater than 5 cm
History of hepatorenal diseases
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
100 patients with inclusion criteria will selected and blocked randomly alocated in to two groups of 50
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
Ethic committee of Isfahan university of Medical Sciences
Street address
Soffeh st. Azadi Sq, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IR.MUI.REC.1395.167
Health conditions studied
1
Description of health condition studied
ovarian hyper stimulation syndrome
ICD-10 code
E28.1
ICD-10 code description
Hypersecretion of ovarian androgens
Primary outcomes
1
Description
Number and follicle size
Timepoint
every 3 days
Method of measurement
sonographic
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intravenous injection of calcium gluconate 10% (dose: 10 mg with 100 сс normal saline) (Sina Darou Co. IRAN)
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous injection of Hydroxy ethyl starch (dose: 500 cc)(Samen Co. IRAN)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Shahid Beheshti Hospital of Isfahan