Comparison between Dienogest and GnRH agonist on pregnancy outcome after laparoscopic surgery in endometriosis.
Design
This is a randomized double-blind ,placebo control, phase 3 clinical trial involving a total of 200 patients; 100patients in the case group allocated to 30 patients in the control group. For randomization, 100 "A" labels and 100 "B" labels covered in envelopes are placed in a box. For each patient an evelope is drawn out of the box. The physician, the patients, and the data analyst are be blinded to groups assignments.
Settings and conduct
This randomized, double-blinded ,clinical trial with a case group (dinogest) control group (Gnrh_a) will be conducted at the IVF clinic of Yas Hospital. Random allocation will be used regarding case and control groups. The investigator, and data analysts will be blinded to the group assignments.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Endometriosis; deep infilterating endometriosis; Infertility Exclusion criteria: Hypersensitivity to dinogest or Gnrh_agonist
Intervention groups
Intervention group:After laparoscopic Surgery for Sever Endometriosis and DIE 100 patients will use Tablet Dinogest for three months.
Main outcome variables
Take home baby
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N40
Registration date:2024-04-02, 1403/01/14
Registration timing:prospective
Last update:2024-04-02, 1403/01/14
Update count:0
Registration date
2024-04-02, 1403/01/14
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
2024-04-19, 1403/01/31
Expected recruitment end date
2025-04-20, 1404/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Dienogest and GnRH agonist on pregnancy outcome of infertile endometriosis women after laparoscopy
Public title
Dinogest effect on pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Deep infilterating endometriosis
Infertility
Exclusion criteria:
Hypersensitivity to dinogest or Gnrh_agonist
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
In Random allocation rule: First 100 letters A and 100 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)
Double blinded
Blinding description
Physician who evaluate outcome is blinded regarding the groups ,and analyzer only sees the codes in data sheet .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of medical sciences
Street address
Sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1597815978
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.680
Health conditions studied
1
Description of health condition studied
Infertility due to endometriosis
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
Ongoing pregnancy
Timepoint
After 20 weeks of pregnancy
Method of measurement
History taking
Secondary outcomes
empty
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, Villa Street
City
Tehran
Province
Tehran
Postal code
1597815978
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
Ali Akbari sari
Street address
Sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1597815978
Phone
+98 21 6644 0000
Email
Herc.tums@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 Avenue, Villa Street
City
Tehran
Province
Tehran
Postal code
1597815978
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
Tehran
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Avenue, Villa Street
City
Tehran
Province
Tehran
Postal code
1597815978
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 Avenue, Villa Street
City
Tehran
Province
Tehran
Postal code
1597815978
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
SPSS FILE
When the data will become available and for how long
After publishing article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Related scientific analysis
From where data/document is obtainable
Email to Fatedavtanha@gmail.com
What processes are involved for a request to access data/document