Evaluation of the recurrence of dysmenorrhea,chronic pelvic pain and sonographic symptoms of endometrioma after laparoscopic surgery in the OCP alone treated group compared with the OCP plus N-acetylcysteine group
Determination of the recurrence of dysmenorrhea,chronic pelvic pain and sonographic symptoms of endometrioma after laparoscopic surgery in the OCP alone treated group compared with the OCP plus N-acetylcysteine group
Design
Double-blind randomized clinical trial with parallel groups and 1: 1 ratio
Settings and conduct
This study will be conducted at Laparoscopic Center of Arash Hospital on women with endometrioma who are eligible for the study after receiving written consent. After completing the demographic questionnaire, the participants will be divided into two groups. The first group will receive N-acetylcysteine 600 mg, three times a day, in 3 days a week for three months with continuous OCP for 6 months. The second group will continuously receive OCP alone for 6 months without the N-acetylcysteine. Blood samples will be taken from participants for measurement of Anti-Mullerian Hormone (AMH) and CA-125 Level once before operation and AMH level be rechecked 6 Months after operation.
Participants/Inclusion and exclusion criteria
Single women with endometrioma (based on the results of ultrasound and laparoscopy) who do not plan to become pregnant after surgery will be enrolled in the study.
Intervention groups
Group 1: Treatment with continuous OCP for 6 months plus N-acetylcysteine effervescent tablets for 3 months.
Group 2: Treatment with continuous OCP alone for 6 months
Main outcome variables
Recurrence of dysmenorrhea; pelvic pain and ultrasound symptoms of endometrioma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110530006640N4
Registration date:2018-04-16, 1397/01/27
Registration timing:registered_while_recruiting
Last update:2018-04-16, 1397/01/27
Update count:0
Registration date
2018-04-16, 1397/01/27
Registrant information
Name
Zahra Asgari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
asgariza@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the recurrence of dysmenorrhea,chronic pelvic pain and sonographic symptoms of endometrioma after laparoscopic surgery in the OCP alone treated group compared with the OCP plus N-acetylcysteine group
Public title
Comparison of the effect of OCP alone and in combination with N-acetylcysteine on clinical and ultrasound signs of endometrioma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
being single
Not having a tendency to pregnancy
Diagnosis of ovarian endometrioma by ultrasound and confirmation by laparoscopic surgery
Exclusion criteria:
Patients who are planning a pregnancy after laparoscopic surgery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size is 112 , with 56 people in each group. Block randomization method was designed by the group's epidemiologist using Stata version 13 software. The size of blocks considered is 6.
Blinding (investigator's opinion)
Double blinded
Blinding description
The random allocation list for patients is solely available to the epidemiologist. To hide the random allocation process, 112 card sequences of treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. On each 10-digit random code packet, the order is written and the framework is written that the patient identification number is relevant and the methodologist will simply be aware of the design of the code. When the physician announces the eligibility of a patient, the methodologist will provide the envelope. The person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and who is unaware of all the processes performed will be used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1724
Health conditions studied
1
Description of health condition studied
Ovarian endometrioma
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Ultrasound recurrence of endometrioma
Timepoint
Once before surgery and once 3 months after surgery and once at the end of the study (6 months after surgery)
Method of measurement
Transvaginal ultrasonically assessment of the ovaries
2
Description
Dysmenorrhea recurrence
Timepoint
Once before surgery and once 3 months after surgery and once at the end of the study (6 months after surgery)
Method of measurement
Visual Analog Scale (VAS)
3
Description
Pelvic Pain Recurrence
Timepoint
Once before surgery and once 3 months after surgery and once at the end of the study (6 months after surgery)
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: The first group will receive N-acetylcysteine 600 mg, three times a day, in 3 days a week for three months with continuous OCP for 6 months.
Category
Treatment - Drugs
2
Description
Group 2: The second group will continuously receive OCP alone for 6 months without the N-acetylcysteine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Dr.Zahra Asgari
Street address
Arash Women 's Hospital, Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
Email
Dr.zahra.asgari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Sahraeian
Street address
Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Asgari
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
asgariza@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Asgari
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
asgariza@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arezoo Maleki Hajiagha
Position
MS , Employee of research development center
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
Email
arezoomaleki.h@yahoo.com
Web page address
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