Protocol summary

Summary
The aim of this study was to evaluate the outcome of N-acetyl-L-cysteine (NAC), as an antioxidant on semen quality, protamine deficiency, DNA fragmentation, reactive oxygen species (ROS) and fertility in individuals with varicocele following varicocelectomy. The study included 35 infertile men with varicocele grade II and III who were referred to Isfahan fertility and infertility center for varicocelectomy.This study was designed similar to a double blind clinical trial that patients and researchers were blinded to type of treatment. This individuals were randomly divided into control (n=20) and NAC (n=15) groups. In the control group, the individuals received placebo post varicocelectomy. In the treatment group or NAC group, the individuals received three tablets of NAC post varicocelectomy (200 mg daily) for three months. Semen parameters (according World Health Organization (WHO) criteria), protamine content (Chromomycin A3), DNA Fragmentation (TUNEL) and ROS statues (DCFH-DA and flow cytometery) were assessed before and three months after varicocelectomy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201508177223N5
Registration date: 2015-10-19, 1394/07/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-19, 1394/07/27
Registrant information
Name
Mohammad Hossein Nasr-Esfahani
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Country
Iran (Islamic Republic of)
Phone
+98 31 9501 5688
Email address
mh_nasr@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2012-05-14, 1391/02/25
Expected recruitment end date
2014-07-02, 1393/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of N-Acetyl cysteine on sperm parameters, sperm chromatin and oxidative s
Public title
The effect of N-Acetyl cysteine on sperm function, after Varicocelectomy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Infertile men with primary infertility and left-sided varicocele (grade II and III) and without female factor infertility. Exclusion criteria: Men with grade I varicocele, Azoospermia, leukocytospermia, anatomical disorders, consumption of drug and occupational exposure
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Commitee of Royan Institue
Street address
Hafez St, Baniha shem St, Resalat Ave, Tehran, Iran, Royan Institute
City
Tehran
Postal code
Approval date
2015-09-07, 1394/06/16
Ethics committee reference number
IR.ACECR.ROYAN.REC.1394.30

Health conditions studied

1

Description of health condition studied
Male factor infertility
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
Sperm motility
Timepoint
In day of surgery
Method of measurement
Optical microscope, based WHO criteria (2010)

2

Description
Sperm concentration
Timepoint
In day of surgery
Method of measurement
Optical microscope, based WHO criteria (2010)

3

Description
Sperm morphology
Timepoint
In day of surgery
Method of measurement
Optical microscope, based WHO criteria (2010)

4

Description
DNA fragmentation
Timepoint
In day of surgery
Method of measurement
Fluorescent microscope

5

Description
Percentages of ROS positive sperm
Timepoint
In day of surgery
Method of measurement
flow cytometery

6

Description
Protamine deficiency
Timepoint
In day of surgery
Method of measurement
Fluorescent microscope

7

Description
Pregnancy outcome
Timepoint
3 months post-surgery
Method of measurement
phone

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group or NAC group: the individuals with varicocele received three tablets of NAC post varicocelectomy (200 mg daily) for three months.
Category
Treatment - Drugs

2

Description
Control group: The individuals with varicocele received placebo after varicocelectomy.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Fertility and Infertility Center
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Street address
Salman Farsi St, Isfahan, Iran,
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Abdolhossein Shahverdi
Street address
Hafez St, Banihashem St, Resalat Ave, Tehran, Iran, Royan Institute
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
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
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor
Other areas of specialty/work
Street address
Royan St, Salman St, KHorasgan, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor
Other areas of specialty/work
Street address
Royan St, Salman St, KHorasgan, Isfahan, Iran,
City
Isfahan
Postal code
Phone
+98 95015688
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr Esfahani
Position
Professor
Other areas of specialty/work
Street address
Royan St, Salman St, KHorasgan, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
Email
Mh_nasr@med.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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