90 couples with unexplained recurrent miscarriage include in study.
first spem analysis and chromatin tests to DNA fragmentation measure ,aniline blue, stained chromomycin A3 assessment will done. Then patient will divide in 3 groups.
1 control
2 recive vit E + selenium daily
3 recive vit E+ zinc daily.
after 3 months second spem analysis and chromatin tests to DNA fragmentation measure ,aniline blue, stained chromomycin A3 assessment will done. result will analyse and compare between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704195261N3
Registration date:2017-05-08, 1396/02/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-08, 1396/02/18
Registrant information
Name
Tahereh Rahiminia
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4490 4272
Email address
t_rahiminia@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
research and clinical center of infertility grant.
Expected recruitment start date
2017-05-04, 1396/02/14
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of antioxidants on sperm molecular chromatin in recurrent pregnancy loss
Public title
Evaluation the effects of antioxidants on sperm molecular chromatin in recurrent pregnancy loss
Purpose
Treatment
Inclusion/Exclusion criteria
All couples with recurrent pregnancy loss included.
varicocele, Cryptorchidism, addicted male and heavy smokersT up of 50 years old male excluded from study.
Age
From 18 years old to 49 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and clinical center of infertility. shahid sadoughi
Street address
Bu Ali street, Safaeyeh, Yazd
City
Yazd
Postal code
Approval date
2014-09-14, 1393/06/23
Ethics committee reference number
340
Health conditions studied
1
Description of health condition studied
Recurrent pregnancy loss
ICD-10 code
N96
ICD-10 code description
habitual or recurrent N96 without current pregnancy N96 Loss (of) pregnancy
Primary outcomes
1
Description
Sperm count
Timepoint
3 months
Method of measurement
2010WHO Guidelines
2
Description
Sperm motility
Timepoint
3 months
Method of measurement
2010 WHO Guidelines
3
Description
Sperm morpholigy
Timepoint
3 months
Method of measurement
2010 WHO Guidelines
4
Description
Dna fragmentation
Timepoint
3 months
Method of measurement
2010 WHO Guidelines
5
Description
Protamine ratio
Timepoint
3 months
Method of measurement
2010 Who Guidelines
6
Description
Histone ratio
Timepoint
3 montha
Method of measurement
2010 WHO Guidelines
Secondary outcomes
empty
Intervention groups
1
Description
control
Category
Lifestyle
2
Description
vit E(400 mg)+ selenium(200 mg), daily. 3 months
Category
Treatment - Drugs
3
Description
vit E(400 mg)+ zinc(30 mg), daily, 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences.
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Ali Reza Talebi
Street address
Bu Ali street, Safaeyeh, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Clinical Center for Infertility, Shahid Sadoughi 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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Soheila Pourmasumi
Position
Ph.D candidate
Other areas of specialty/work
Street address
Bu Ali street, Safaeyeh, Yazd
City
Yazd
Postal code
Phone
+98 35 3824 7087
Fax
Email
spourmasumi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pourmasumi
Full name of responsible person
Soheila
Position
Ph.D candidate
Other areas of specialty/work
Street address
Bu Ali street, Safaeyeh, Yazd
City
Yazd
Postal code
Phone
+98 35 3824 7087
Fax
Email
spourmasumi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pourmasumi
Full name of responsible person
Soheila
Position
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Other areas of specialty/work
Street address
Ph.D candidate
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)