The effect of alpha-lipoic acid on DNA fragmentation in the treatment of patients with recurrent abortion
Design
the controlled clinical trial, with parallel groups, two-way blind, randomized, on 40 patients. Computer random assignment list produced with PASS software.
Settings and conduct
This is a double-blind randomized clinical trial. Couples with a history of recurrent miscarriage who have been referred to Milad Infertility Center during 1300-1400 and meet the inclusion criteria are included in the study. The number of samples is about 20 people in each group. Individuals undergo initial semen liquid evaluation and their sperm are examined for DNA fragmentation index (DFI) by the SCSA method. In the case of DFI> 30%, using a simple randomization method and random number table, patients are assigned to two groups of placebo and intervention group. The study group received 300 mg of alpha-lipoic acid tablets 3 daily for 3 months. The placebo group also receives 300 mg tablets, very similar to the alpha-lipoic acid tablets 3 daily for 3 months.
Participants/Inclusion and exclusion criteria
Couples with a history of recurrent miscarriage with a DFI of more than 30% who refer to Milad Infertility Centers and meet the inclusion criteria are included in the study. Inclusion criteria: no history of PCO, no chronic ovulation, and no other tubular and anatomical causes, and no history of medical diseases and are willing to participate in the project. Subjects will be asked not to take any other supplements during the research.
Exclusion criteria: Drug allergies and the occurrence of drug side effects such as hypotension and occasional hypoglycemia, anemia, and patients who did not take the drug regularly
Intervention groups
The study group received 300 mg of alpha-lipoic acid tablets, 3 daily for 3 months
Main outcome variables
DNA Fragmentation Index (DFI) sperm rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041503N4
Registration date:2021-08-18, 1400/05/27
Registration timing:registered_while_recruiting
Last update:2021-08-18, 1400/05/27
Update count:0
Registration date
2021-08-18, 1400/05/27
Registrant information
Name
Malihe Mahmoudinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9878
Email address
mahmoudiniam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of alpha-lipoic acid antioxidant on sperm DNA Fragmentation in the treatment of recurrent abortion
Public title
The effect of an antioxidant on couple fertility with recurrent abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Couples with a history of recurrent miscarriage and DFI >30%
willingness to participate in the study
Normal karyotype
Thyroid, prolactin, and thrombophilic and phospholipid tests are normal
Exclusion criteria:
PCO and chronic anovulation
presence of tubal and anatomical disease of the uterus
Dissatisfaction with participation in the study
presence of underlying disease
Allergic drug reaction
Side effects of the drug such as hypotension and occasional hypoglycemia and anemia
Not taking the medicine regularly
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
-In this randomized clinical trial 40 patients, two groups were randomly assigned.
-Method used to generate random allocation sequence by mentioning the name of the software or site used: Computer random assignment list produced with PASS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is unaware of the treatment, patients are coded A and B based on random assignment, and the researcher gives the drug to the patient based on patient code A or B. The statistical consultant who analyzes the data is unaware of the grouping.
Placebo
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
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-07-06, 1400/04/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.209
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46.9
ICD-10 code description
Male infertility, unspecified
Primary outcomes
1
Description
Examination of sperm DNA fragmentation
Timepoint
Before starting treatment and then, after 3 months of treatment
Method of measurement
Examination of blood samples using SCSA method
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received 300 mg of alpha lipoic acid tablets made by the Raha Daroo Company, 3 daily for 3 months
Category
Treatment - Drugs
2
Description
The placebo group also receives 300 mg tablets, very similar to the alpha-lipoic acid tablets made by the School of Pharmacy, 3 daily for 3 months This medicine is provided by Raha Daroo Company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility center
Full name of responsible person
Nayereh Khadem
Street address
Milad Infertility center, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
khademn@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen, Tafaghodi
Street address
Vice Chancellor of Research, Mashhad university of Medical sciences, university Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Shahabian moghaddam
Position
Specialized assistant for women
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Honarestan
City
Mashhad
Province
Razavi Khorasan
Postal code
9178143179
Phone
+98 51 3883 0663
Email
shahabianmf971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nayereh Khadem
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
خراسان رضوي، مشهد ،مركز نازايي ميلاد
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3583 1204
Email
Khademn@mum.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Mahmoudinia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Milad Infertility center, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
mahmoudiniam@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available