Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201802003076341 Date of Approval: 12/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Different Antioxidants on Sperm Parameters in Infertile Males
Official scientific title Effects of Different Antioxidants on Sperm Parameters in Infertile Males
Brief summary describing the background and objectives of the trial Infertility is defined as inability of a couple to conceive after 12 months of regular unprotected sexual intercourse. Male factor infertility constitutes about half of all cases of infertility. There are many causes of male infertility which may be caused by smoking, urinary tract infection, exposure to radiation, genital tract infection and oxidative stress. Oxidative stress is one of the most important factors contributing to poor quality of semen which occurs when the production of Reactive Oxygen Species (ROS) exceeds the natural antioxidant defense in the body. Leucocytes (particularly neutrophils and macrophages) and Immature spermatozoa are the two main sources of ROS. The aim of this study is to evaluate the effect of certain antioxidants on the semen parameters.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Male factor infertility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-male
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2016
Actual trial start date 15/02/2016
Anticipated date of last follow up 31/01/2017
Actual Last follow-up date 31/01/2017
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitamin C and Zinc vitamin C 1000 mg and zinc 20 mg 12 weeks once daily, orally 35
Experimental Group Acetyl cysteine and Selenium Acetyl cysteine 200 mg and selenium 100 mcg 12 weeks once daily, orally 35
Experimental Group Vitamin E and Folic acid vitamin E 1000 mg and folic acid 400 mcg 12 weeks once daily, orally 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male factor primary infertility Azospermia Testicular atrophy Hepatitis C Drug addicts 20 Year(s) 40 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/02/2016 IRB: The ethics committee of the Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, El-Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sperm motility Before treatment After 12 weeks of treatment
Primary Outcome Sperm concentration Before treatment After 12 weeks of treatment
Primary Outcome Sperm morphology (normal forms) Before treatment After 12 weeks of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology, Elshatby Maternity Hospital, Faculty of Medicine, University of Alexandria Elshatby Maternity Hospital, Port Said Street, ElShatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Obstetrics, Faculty of Medicine, University of Alexandria 17Chamblion street, el azareeta Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, University of Alexandria 17Chamblion street, el azareeta Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Abdelmoaty Elsamra 175 Horyia Street, Ibrahimia Alexandria 21524 Egypt
Sherif Mansour Agag 4 Hamed ElKohly Street, San Stifano Alexandria 21532 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elsamra melsamra@yahoo.com 002-01111113015 175 Horyia Street, Ibrahimia
City Postal code Country Position/Affiliation
Alexandria 21524 Egypt Professor of Obstetrics and Gynaecology, Faculty of Medicine, University of Alexsndria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Sherif Aggag Sherif_aggag@yahoo.com 002-01223271716 4 Hamed ElKohly Street, San Stifano
City Postal code Country Position/Affiliation
Alexandria 21532 Egypt Consultant, Department of Clinical Pathology, Egyptian Ministry of Health, Alexandria, Egypt.
REPORTING
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