The objective of this random controlled clinical trial, sampling in single reference center and convenient sampling, is to investigate the effects of antioxidative treatments on pregnancy results. In this study 150 infertile candidates for IUI which qualified for the inclusion criteria: normal hormonal analysis; at least one open fallopian tube in hysterosalpingography; the absence of cervicitis and exclusion criteria: Irregular menstruation; galactorrhea; abnormal hysterosalpingography, will randomly assigned into intervention or control group. The patients in the intervention group will receive vitamin C, E, Zinc and w3 supplement and control group will received no treatment. DNA fragmentation and its effects in the results of pregnancy with IUI, will evaluate in 5 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306115942N2
Registration date:2013-08-26, 1392/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-26, 1392/06/04
Registrant information
Name
Aliye Ghasemzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9160
Email address
gasemzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-06-10, 1392/03/20
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of antioxidative treatments on sperm DNA fragmentation and pregnancy results in IUI
Public title
Effects of antioxidative treatments on pregnancy results
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: normal hormonal analysis; infertile women candidates for IUI method; age at least 25 years old and less than 40years old; body mass index minimum 19 kg/m² and less than 30 kg/m²; at least one open fallopian tube in hysterosalpingography; the absence of cervicitis or clinical cervical lesion; SDF (Sperm DNA Fragmentation) less than 30%; the absence of infection in accessory glands; lack of drug addiction and smoking; the absence of varicocele.
Exclusion criteria: Irregular menstruation;Galactorrhea; abnormal hysterosalpingography; obstruction in fallopian; adhesion of fallopian; past medical peritoneal surgery; infection in accessory glands
Age
From 25 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tabriz University of Medical Sciences
Street address
Building No.2 of Research Vice-Chancellor,Tabriz University of Medical Sciences,Tabriz
City
Tabrize
Postal code
Approval date
2012-09-11, 1391/06/21
Ethics committee reference number
5498/4/5
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male
2
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
3
Description of health condition studied
Infertility
ICD-10 code
N97.3
ICD-10 code description
Female infertility of cervical origin
Primary outcomes
1
Description
sperm DNA fragmentation
Timepoint
Before interposition, 2 month after interposition
Method of measurement
Observation with optic microscope
Secondary outcomes
1
Description
Pregnancy outcomes
Timepoint
Two weeks after IUI
Method of measurement
Pregnancy occurence after positive blood HCG assay
Intervention groups
1
Description
one group,vitamin C orally adminstrated daily with 1000 mg dosage for two month.
Category
Treatment - Drugs
2
Description
Control group without any treatment
Category
Treatment - Drugs
3
Description
one group,zn Supplement orally adminstrated daily with 30mg dosage for two month.
Category
Treatment - Drugs
4
Description
one group,vitamin E orally adminstrated daily with 400 mg dosage for two month.
Category
Treatment - Drugs
5
Description
one group,W3 Supplement orally adminstrated daily with1000mg dosage for two month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Al-Zahra Hospital
Full name of responsible person
Doctor Aliye Ghasemzadeh
Street address
Al Zahra Hospital, Bagshomal Crossroad, Southern Artesh St., Tabriz