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Eeffect of oral administration of N- acetyl cysteine on decrease of oxidative stress , Concentration of heavy metals and lipid profile in Women with Endometriosis

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History
# Registration date Revision Id
2 2020-05-16, 1399/02/27 134527
1 2020-01-27, 1398/11/07 119617
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  • Protocol summary

    Endometriosis, 20-45 years old, obesity , not taking antioxidants and non-clinical, or surgical treatment in the past 6 months, no chronic diseases such as: hepatitis, thalassemia anemia, diabetes , infectious diseases and Inflammatory.
    Endometriosis, 20-45 years old, not taking antioxidants and non-clinical, or surgical treatment in the past 6 months, no chronic diseases such as: hepatitis, thalassemia anemia, diabetes , infectious diseases and Inflammatory.
    ابتلا به اندومتریوز ، سن 20-45سال ،زنان چاق ، عدم مصرف آنتی اکسیدان ها ,درمان بالینی و یا جراحی طی 6 ماه گذشته ،عدم ابتلا به بیماری های مزمن از قبیل : هپاتیت، کم خونی ،تالاسمی دیابت، بیماری های عفونی و التهابی.
    ابتلا به اندومتریوز ، سن 20-35سال ، عدم مصرف آنتی اکسیدان ها ,درمان بالینی و یا جراحی طی 6 ماه گذشته ،عدم ابتلا به بیماری های مزمن از قبیل : هپاتیت، کم خونی ،تالاسمی دیابت، بیماری های عفونی و التهابی.

  • General information

    45
    35
    empty
    Modification of sample age and incorrect typing correction
    empty
    اصلاح رنج سنی نمونه ها و اصلاح غلط تایپی
    Women with endometriosis
    َAge 20-45 years old
    Laparoscopic diagnosis of endometriosis
    Not taking antioxidant supplements
    Lack of chronic diseases such as: diabetes- hepatitis- thalassemia anemia-infectious and inflammatory diseases
    No clinical or surgical treatment for the past six months
    Lack of polycystic ovary
    Women with endometriosis
    َAge 20-35 years old
    Laparoscopic diagnosis of endometriosis
    Not taking antioxidant supplements
    Lack of chronic diseases such as: diabetes- hepatitis- thalassemia anemia-infectious and inflammatory diseases
    No clinical or surgical treatment for the past six months
    Lack of polycystic ovary
    زنان مبتلا به اندومتریوز
    سن 20-45 سال
    تشخیص اندومتریوز برمبنای لاپاروسکوپی
    عدم مصرف مکمل های آنتی اکسیدانی
    عدم ابتلا به بیماری های مزمن مانند: دیابت- هپاتیت- کم خونی تالاسمی- بیماری های عفونی و التهابی
    عدم درمان بالینی و یا جراحی طی شش ماه گذشته
    عدم ابتلا به تخمدان پلی کیستیک
    زنان مبتلا به اندومتریوز
    سن 20-35 سال
    تشخیص اندومتریوز برمبنای لاپاروسکوپی
    عدم مصرف مکمل های آنتی اکسیدانی
    عدم ابتلا به بیماری های مزمن مانند: دیابت- هپاتیت- کم خونی تالاسمی- بیماری های عفونی و التهابی
    عدم درمان بالینی و یا جراحی طی شش ماه گذشته
    عدم ابتلا به تخمدان پلی کیستیک

  • Recruitment centers

    #1
    Name of recruitment center - English: Infertility and Reproductive Health Research Center
    Name of recruitment center - Persian: مرکز تحقیقات سلامت باروری و ناروری
    Full name of responsible person - English: Dr Sadighe Esmaeilzadeh
    Full name of responsible person - Persian: دکتر صدیقه اسماعیل زاده
    Street address - English: Infertility and Reproductive Health Research Center, Fatemeh Zahra Hospital, Babol, Iran
    Street address - Persian: ایران -بابل- بیمارستان فاطمه زهرا- مرکز تحقیقات سلامت باروری و ناروری
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone: +98 11 3227 4882
    Fax:
    Email: sesmael2010@gmail.com
    Web page address:
    Name of recruitment center - English: Infertility and Reproductive Health Research Center
    Name of recruitment center - Persian: مرکز تحقیقات سلامت باروری و ناروری
    Full name of responsible person - English: Dr Sadighe Esmaeilzadeh
    Full name of responsible person - Persian: دکتر صدیقه اسماعیل زاده
    Street address - English: Infertility and Reproductive Health Research Center, Fatemeh Zahra Hospital, Babol, Iran
    Street address - Persian: ایران -بابل- بیمارستان فاطمه زهرا- مرکز تحقیقات سلامت باروری و ناروری
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 47176-47745
    Phone: +98 11 3227 4882
    Fax:
    Email: sesmael2010@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Reza Ghadimi
    Full name of responsible person - Persian: دکتر رضا قدیمی
    Street address - English: Babol-Babol University of Medical Sciences
    Street address - Persian: بابل- خیابان گنج افروز- دانشگاه علوم پزشکی
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone: +98 11 3219 0557
    Fax:
    Email: rezaghadimi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Reza Ghadimi
    Full name of responsible person - Persian: دکتر رضا قدیمی
    Street address - English: University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
    Street address - Persian: ایران،مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 47176-47745
    Phone: +98 11 3219 0557
    Fax:
    Email: rezaghadimi@yahoo.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Prof. Soleiman Mahjoub
    Full name of responsible person - Persian: پروفسور سلیمان محجوب
    Position - English: Ph.D.
    Position - Persian: Ph.D
    Latest degree: phd
    Area of specialty/work: 25
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Biochemistry , Babol University of Medical Sciences
    Street address - Persian: بابل- دانشگاه علوم پزشکی بابل- گروه بیوشیمی
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 47176-47745
    Phone: +98 11 3219 0569
    Mobile: +98 911 113 0532
    Fax:
    Email: smahjoub20@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Prof. Soleiman Mahjoub
    Full name of responsible person - Persian: پروفسور سلیمان محجوب
    Position - English: Ph.D.
    Position - Persian: Ph.D
    Latest degree: phd
    Area of specialty/work: 25
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Biochemistry , Babol University of Medical Sciences
    Street address - Persian: بابل- دانشگاه علوم پزشکی بابل- گروه بیوشیمی
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 47176-47745
    Phone: +98 11 3219 0569
    Mobile: +98 911 113 0532
    Fax: +98 11 3219 0569
    Email: smahjoub20@yahoo.com
    Web page address:

Protocol summary

Study aim
Evaluation of oral N-acetylcysteine administration on reduction of oxidative stress, heavy metal concentration and serum lipid profile in women with endometriosis
Design
This is a parallel, non-blinded, randomized controlled clinical trial
Settings and conduct
this study will be done at the Fatemezahra Infertility Center of Babol University of Medical Sciences. Sixty women with endometriosis will be divided into two groups (30 in each group), intervention group will be received routine treatment with n-acetylcysteine and comparison group received routine treatment. Index of lipid peroxidation, total antioxidant capacity and carbonyl will be measured. Determination of iron and lactate dehydrogenase in blood samples of patients by spectrophotometric method and determination of 8-hydroxy-2-doxy guanosine as an indicator of DNA oxidative stress by ELISA and heavy metals by atomic absorption and lipid indices Spectrophotometry will be performed.
Participants/Inclusion and exclusion criteria
Endometriosis, 20-45 years old, not taking antioxidants and non-clinical, or surgical treatment in the past 6 months, no chronic diseases such as: hepatitis, thalassemia anemia, diabetes , infectious diseases and Inflammatory.
Intervention groups
The experimental group will receive routine treatment and a 6-week oral administration of N-acetylcysteine at a daily dose of 8.1 g daily (3 g daily for obese women). The control group will receive only routine treatment.
Main outcome variables
Malondialdehyde, lactate dehydrogenase, total antioxidant capacity, zinc, copper, lead, cadmium, nickel, chromium and lipid indices.

General information

Reason for update
Modification of sample age and incorrect typing correction
Acronym
IRCT registration information
IRCT registration number: IRCT20100411003684N9
Registration date: 2020-01-27, 1398/11/07
Registration timing: registered_while_recruiting

Last update: 2020-05-16, 1399/02/27
Update count: 1
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Soleiman Mahjoub
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0569
Email address
s.mahjoub@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for research of Babol University of Medical Sciences
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Eeffect of oral administration of N- acetyl cysteine on decrease of oxidative stress , Concentration of heavy metals and lipid profile in Women with Endometriosis
Public title
Eeffect of oral administration of N- acetyl cysteine in Women with Endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with endometriosis َAge 20-35 years old Laparoscopic diagnosis of endometriosis Not taking antioxidant supplements Lack of chronic diseases such as: diabetes- hepatitis- thalassemia anemia-infectious and inflammatory diseases No clinical or surgical treatment for the past six months Lack of polycystic ovary
Exclusion criteria:
Non-use of medication Thalassemia. Diabetes- Hepatitis- Anemia-Infectious and Inflammatory diseases.
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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
Ethics Committee of Babol University of Medical Sciences
Street address
University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Tehran
Postal code
47176-47745
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
MUBABOL.HRI.REC.1393.1671

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80.8
ICD-10 code description
Other endometriosis

Primary outcomes

1

Description
Malondialdehyde (MDA)
Timepoint
6 Weeks
Method of measurement
TBARS Method (Spectrophotometry)

2

Description
Total antioxidant capacity (TAC)
Timepoint
6 Weeks
Method of measurement
FRAP Method

3

Description
Blood Iron
Timepoint
6 Weeks
Method of measurement
Spectrophotometry

4

Description
Lactate dehydrogenase (LDH)
Timepoint
6 Weeks
Method of measurement
Spectrophotometry

5

Description
8-OH-2-deoxy-Guanosine (8-OHdG)
Timepoint
6 Weeks
Method of measurement
ELISA

6

Description
Carbonyl
Timepoint
6 Weeks
Method of measurement
Levin Method

7

Description
DPPH index
Timepoint
6 Weeks
Method of measurement
Spectrophotometry

Secondary outcomes

1

Description
Levels of Lead
Timepoint
6 week
Method of measurement
Atomic absorption

2

Description
Levels of cadmium
Timepoint
6 Week
Method of measurement
Atomic absorption

3

Description
Levels of nickel
Timepoint
6 Week
Method of measurement
Atomic absorption

4

Description
Levels of chromium
Timepoint
6 Week
Method of measurement
Atomic absorption

5

Description
Levels of High Density Lipoprotein (HDL)
Timepoint
6 Week
Method of measurement
Spectrophotometer

6

Description
Levels of Low Density Lipoprotein (LDL)
Timepoint
6 Week
Method of measurement
Spectrophotometer

7

Description
Levels of Triglyceride
Timepoint
6 Week
Method of measurement
Spectrophotometer

8

Description
Levels of Cholesterol
Timepoint
6 Week
Method of measurement
Spectrophotometer

9

Description
Levels of Cu
Timepoint
6 Week
Method of measurement
Spectrophotometer

10

Description
Levels of Zn
Timepoint
6 Week
Method of measurement
Spectrophotometer

11

Description
Levels of Zn
Timepoint
6 Week
Method of measurement
Spectrophotometer

12

Description
Level of Carbonyl
Timepoint
6 Week
Method of measurement
Spectrophotometer

13

Description
DPPH Index
Timepoint
6 Week
Method of measurement
Spectrophotometer

Intervention groups

1

Description
Oral administration of N- acetyl cysteine with dose of 1/8 gr/day (overweight women 3 gr/day) during 6 weeks in addition to routine medication in women with endometriosis.
Category
Treatment - Drugs

2

Description
The control group will be received routine medication.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility and Reproductive Health Research Center
Full name of responsible person
Dr Sadighe Esmaeilzadeh
Street address
Infertility and Reproductive Health Research Center, Fatemeh Zahra Hospital, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3227 4882
Email
sesmael2010@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0557
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
913438
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Prof. Soleiman Mahjoub
Position
Academic member
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0569
Fax
Email
smahjoub20@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Prof. Soleiman Mahjoub
Position
Academic member
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry, Babol University of Medical Sciences, Babol
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1219 0569
Fax
Email
s.mahjoub@mubabol.ac.ir
Web page address
https://www.researchgate.net/profile/Prof_Dr_Soleiman_Mahjoub2/?ev=hdr_xprf

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Prof. Soleiman Mahjoub
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Biochemistry , Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0569
Fax
+98 11 3219 0569
Email
smahjoub20@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on the main outcome will be available
When the data will become available and for how long
Six months after the publication of result
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is not yet known
From where data/document is obtainable
professor Soleiman Mahjoub smahjoub20@yahoo.com OR s.mahjoub@mubabol.ac.ir
What processes are involved for a request to access data/document
Two weeks after application
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