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Protocol summary
A randomized clinical trial on 100 patients with Deep infilterating endometriosis after laparoscopic surgery will be conducted in case group (table Dienogest 2mg/d for 3months) or control group(Gnrh_agonist for 3 months), then pelvic pain & fertility outcome will be evaluated.
A randomized clinical trial on 104 patients with Deep infilterating endometriosis after laparoscopic surgery will be conducted in case group (table Dienogest 2mg/d for 3months) or control group(Gnrh_agonist for 3 months), then pelvic pain & fertility outcome will be evaluated.
A randomized clinical trial on 100104 patients with Deep infilterating endometriosis after laparoscopic surgery will be conducted in case group (table Dienogest 2mg/d for 3months) or control group(Gnrh_agonist for 3 months), then pelvic pain & fertility outcome will be evaluated.
در یک کارآزمایی بالینی تصادفی تعداد ۱۰۰ بیمارمبتلا به اندومتریوز عمقی دریکی از دوگروه مورد(مصرف قرص داینوژست روزانه تا سه ماه) یاگروه کنترل(مصرف آگونیست GNRH برای سه ماه) قرار گرفته وسپس درد لگنی وپیامد باروری آنها بررسی میشود.
در یک کارآزمایی بالینی تصادفی تعداد 104 بیمارمبتلا به اندومتریوز عمقی دریکی از دوگروه مورد(مصرف قرص داینوژست روزانه تا سه ماه) یاگروه کنترل(مصرف آگونیست GNRH برای سه ماه) قرار گرفته وسپس درد لگنی وپیامد باروری آنها بررسی میشود.
در یک کارآزمایی بالینی تصادفی تعداد ۱۰۰104 بیمارمبتلا به اندومتریوز عمقی دریکی از دوگروه مورد(مصرف قرص داینوژست روزانه تا سه ماه) یاگروه کنترل(مصرف آگونیست GNRH برای سه ماه) قرار گرفته وسپس درد لگنی وپیامد باروری آنها بررسی میشود.
After laparoscopic Surgery for Sever Endometriosis and DIE 100 patients will use Tablet Dinogest for three months
After laparoscopic Surgery for Sever Endometriosis and DIE 52 patients will use Tablet Dinogest for three months
After laparoscopic Surgery for Sever Endometriosis and DIE 10052 patients will use Tablet Dinogest for three months
بعد از جراحی لا پاروسکوپی برای اندومتریوز شدید و تعداد ۱۰۰ نفر از بیماران قرص داینو ژست را برای سه ماه استفاده می کنند
بعد از جراحی لا پاروسکوپی برای اندومتریوز شدید و تعداد 52 نفر از بیماران قرص داینو ژست را برای سه ماه استفاده می کنند
بعد از جراحی لا پاروسکوپی برای اندومتریوز شدید و تعداد ۱۰۰52 نفر از بیماران قرص داینو ژست را برای سه ماه استفاده می کنند
The pelvic painand fertility outcome will be reported for fifty patients in each group.
The pelvic painand fertility outcome will be reported for fifty52 patients in each group.
The pelvic painand fertility outcome will be reported for fiftyfifty52 patients in each group.
بررسی پیامددردلگنی وباروری برروی ۵۰بیماردرهرگروه گزارش میشود.
بررسی پیامددردلگنی وباروری برروی 52 بیماردرهرگروه گزارش میشود.
بررسی پیامددردلگنی وباروری برروی ۵۰52 بیماردرهرگروه گزارش میشود.
In Random allocation rule: First 50 letters A and 50 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (case group) or B (control group) are determined by a lot.
In Random allocation rule: First 52 letters A and 52 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (case group) or B (control group) are determined by a lot.
In Random allocation rule: First 5052 letters A and 5052 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (case group) or B (control group) are determined by a lot.
ابتدا تعداد۵۰عدد حرف A و۵۰عدد حرف B بر روی کاغذهای مخصوص که داخل آن ها مشخص نباشد نوشته می شود. سپس کل آن ها داخل یک کیسه قرار داده می شود و برای هر بیمار پس از کسب رضایت آگاهانه, به طور تصادفی و بدون جایگزینی یک کاغذ برداشته می شود و براساس حرف نوشته روی آن مداخله مورد نظر برای بیمار انجام می شود. در ضمن مداخله A (گروه مورد) یا B (گروه کنترل) با قرعه کشی تعیین می شوند.
ابتدا تعداد 52 عدد حرف A و52 عدد حرف B بر روی کاغذهای مخصوص که داخل آن ها مشخص نباشد نوشته می شود. سپس کل آن ها داخل یک کیسه قرار داده می شود و برای هر بیمار پس از کسب رضایت آگاهانه, به طور تصادفی و بدون جایگزینی یک کاغذ برداشته می شود و براساس حرف نوشته روی آن مداخله مورد نظر برای بیمار انجام می شود. در ضمن مداخله A (گروه مورد) یا B (گروه کنترل) با قرعه کشی تعیین می شوند.
ابتدا تعداد۵۰ 52 عدد حرف A و۵۰و52 عدد حرف B بر روی کاغذهای مخصوص که داخل آن ها مشخص نباشد نوشته می شود. سپس کل آن ها داخل یک کیسه قرار داده می شود و برای هر بیمار پس از کسب رضایت آگاهانه, به طور تصادفی و بدون جایگزینی یک کاغذ برداشته می شود و براساس حرف نوشته روی آن مداخله مورد نظر برای بیمار انجام می شود. در ضمن مداخله A (گروه مورد) یا B (گروه کنترل) با قرعه کشی تعیین می شوند.
Primary outcomes
#1
Evaluation of dysmenorrhoea &dysparunia
Evaluation of dysmenorrhoea &dysparunia and Dyschezia
Evaluation of dysmenorrhoea &dysparunia and Dyschezia
ارزیابی دیسمنوره، دیسپارونی
ارزیابی دیسمنوره، دیسپارونی ، دیسکزیا
ارزیابی دیسمنوره، دیسپارونی ، دیسکزیا
Protocol summary
Study aim
Evaluation of the effect of Dienogest and GnRH agonist on pelvic pain after laparoscopic surgery in endometriosis
Design
A randomized clinical trial on 104 patients with Deep infilterating endometriosis after laparoscopic surgery will be conducted in case group (table Dienogest 2mg/d for 3months) or control group(Gnrh_agonist for 3 months), then pelvic pain & fertility outcome will be evaluated.
Settings and conduct
A randomized clinical trial will be conducted on patients with history of laparoscopy for DIE and medical treatment with dinogest or Gnrh_agonist at Yas hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria : Endometriosis; deep infilterating endometriosis; Infertility
Exclusion criteria: Hypersensitivity to dinogest or Gnrh_agonist
Intervention groups
After laparoscopic Surgery for Sever Endometriosis and DIE 52 patients will use Tablet Dinogest for three months
The pelvic painand fertility outcome will be reported for fifty52 patients in each group.
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N25
Registration date:2022-03-02, 1400/12/11
Registration timing:prospective
Last update:2024-05-23, 1403/03/03
Update count:2
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
2022-04-04, 1401/01/15
Actual recruitment end date
2022-10-12, 1401/07/20
Trial completion date
2023-03-11, 1401/12/20
Scientific title
Evaluation of the effect of Dienogest and GnRH agonist on pelvic pain & pregnancy outcome after laparoscopic surgery in endometriosis
Public title
The effect of Dienogest and GnRH agonist on pelvic pain & pregnancy outcome after laparoscopic surgery in endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Endometriosis
deep infilterating endometriosis
Infertility
Exclusion criteria:
Hypersensitivity to dinogest or Gnrh_agonist
Age
From 20 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
Actual sample size reached:
104
Randomization (investigator's opinion)
Randomized
Randomization description
In Random allocation rule: First 52 letters A and 52 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (case group) or B (control group) are determined by a lot.
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
Ethical Comittee of Tehran University of Medical Sciences
Street address
Yas hospital, North Nejatollahi avenue, Karim khan zand Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.964
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
Evaluation of dysmenorrhoea &dysparunia and Dyschezia
Timepoint
Thre months adter surgery
Method of measurement
Questionnaire for female sexual function index and Questionnaire for visual acuity scale
2
Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Positive BhCG
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Four weeks after embryo transfer
Method of measurement
Vaginal ultrasound
Intervention groups
1
Description
Intervention group: After laparoscopic surgery for Deep infilterating endometriosis tablet Dienogest 2mg/day for three months willbe used.
Category
Treatment - Drugs
2
Description
Control group: After laparoscopic surgery for Deep infilterating endometriosis GNRH AGONIST 11.25 will be used for three months .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital, North Nejatollahi avenue; karim Khan zand Bridge; Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ِDr. Akbar Fotouhi
Street address
Yas hospital; North Nejatollahi Avenue; Karim khan zand Bridge; Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
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
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital; North nejatollahi; Karim Khan zand Bridge; Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital; North Nejatollahi avenue; Karim Khan zand Bridge; Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital; North Nejatollahi; Karim Khan Zand Bridge; Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
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