Comparison of the effect of periodically versus continuously oral contraceptives pills consumption on pain and anatomical recurrence in patients with endometrioma after laparoscopic surgery
comparison of the effect of periodically versus continuously oral contraceptives consumption on pain and anatomical recurrence in patients with endometrioma after laparoscopic surgery
Design
This is a randomized, open-labeled, single-center clinical trial.
Settings and conduct
This clinical trial will be carried out on 154 women attended the Arash Women's Hospital. All women aged 18 to 35 years old undergoing laparoscopic excision of endometrioma will be included in the study. The patients will randomly be divided into two groups: in one group contraceptive pills will be administered for continuous consumption and in another parallel group contraceptive pills will be administered for consumption in a cyclic manner (starting from 5 days of menstruation and continuing for 28 days, then discontinuing and continuing in the next cycle). In both treatment groups, the treatment lasts for one year. Then patients will be evaluated by ultrasound in the 3rd, 6th and 12th months after starting treatment and the endometrioma anatomic recurrence and endometrial thickness will be checked and their pain will be measured by the VAS criteria.
Participants/Inclusion and exclusion criteria
women aged between 18 and 35 years old with a history of laparoscopic endometrioma excision and AMH>=2.5 will be included in the study if did not receive another therapeutics during last 6 months and do not have a contraindication for estrogen or progesterone use.
Intervention groups
group 1: intake of contraceptive pills continuously for one year.
group 2: intake of contraceptive pills in a cyclic manner for one year.
Main outcome variables
pain, ultrasonographic features of endometrioma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140111016161N8
Registration date:2018-12-15, 1397/09/24
Registration timing:retrospective
Last update:2018-12-15, 1397/09/24
Update count:0
Registration date
2018-12-15, 1397/09/24
Registrant information
Name
Reyhaneh Hosseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
r-hosseini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of periodically versus continuously oral contraceptives pills consumption on pain and anatomical recurrence in patients with endometrioma after laparoscopic surgery
Public title
Effect of periodically versus continuously OCP on Endometrioma recurrence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Development of endometrioma
Age range from 18 to 35 years
Unwillingness to pregnancy
Anti-Müllerian hormone (AMH) higher than 2.5
Laparoscopic excision of endometrioma
Exclusion criteria:
Receive other therapies during the last 6 months (except for non-steroidal anti-inflammatory drugs)
Contraindication for estrogen and progesterone regular use
Unwillingness to change in menstrual cycles
Pelvic inflammatory diseases
Varicose veins
known malformations of the genitourinary system in previous surgeries
known urological, orthopedics, gastrointestinal disorders, and psychological disorder.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
We will use the block randomization method by using: www.sealedenvelope.com
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 Tehran University of Medical Science
Street address
Qods Street, Keshavarz Bulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-10-03, 1395/07/12
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.716
Health conditions studied
1
Description of health condition studied
آندومتریوز تخمدان
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
pain
Timepoint
3, 6 and 12 months after treatment starting
Method of measurement
Visual Analogue Scale
2
Description
Anatomical recurrence of ovary endometrium
Timepoint
3, 6 and 12 months after treatment starting
Method of measurement
sonography
Secondary outcomes
1
Description
Drug Complications (Increased Endometrial Thickness)
Timepoint
3, 6, and 12 months after starting treatment
Method of measurement
Ultrasound
2
Description
Drug Complications (Venous thrombosis)
Timepoint
3, 6, and 12 months after starting treatment
Method of measurement
Medical history and physical examination
Intervention groups
1
Description
Intervention group: patients take contraceptive pills continuously for one year.
Category
Treatment - Drugs
2
Description
Control group: patients take contraceptive pill in cyclic form for one year.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr Reyhaneh Hoseini
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
Rayh_h@yahoo.com
Web page address
http://arash.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Central University, Qods St, Keshavarz Blv,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
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 Reihane hoseini
Position
Assistant 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 7771 9922
Fax
+98 21 7788 3196
Email
rayh_h@yahoo.com
Web page address
http://arash.tums.ac.ir/?lang=en
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Reihane Hoseini
Position
Assistant 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 7771 9922
Fax
+98 21 7788 3196
Email
rayh_h@yahoo.com
Web page address
http://arash.tums.ac.ir/?lang=en
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanieh Alam Beigi
Position
gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
h.alambeygi@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