Protocol summary
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Study aim
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Evaluation of the effect of Dienogest and GnRH agonist on pelvic pain after laparoscopic surgery in endometriosis
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Design
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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.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : Endometriosis; deep infilterating endometriosis; Infertility
Exclusion criteria: Hypersensitivity to dinogest or Gnrh_agonist
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Intervention groups
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After laparoscopic Surgery for Sever Endometriosis and DIE 52 patients will use Tablet Dinogest for three months
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Main outcome variables
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Dysmenorrhoea; dysparunia ،Dyschezia; fertility outcome
General information
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Reason for update
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The pelvic painand fertility outcome will be reported for fifty52 patients in each group.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-03-02, 1400/12/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-03-06, 1400/12/15
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Expected recruitment end date
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2022-09-06, 1401/06/15
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Actual recruitment start date
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2022-04-04, 1401/01/15
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Actual recruitment end date
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2022-10-12, 1401/07/20
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Trial completion date
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2023-03-11, 1401/12/20
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Scientific title
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Evaluation of the effect of Dienogest and GnRH agonist on pelvic pain & pregnancy outcome after laparoscopic surgery in endometriosis
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Public title
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The effect of Dienogest and GnRH agonist on pelvic pain & pregnancy outcome after laparoscopic surgery in endometriosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Endometriosis
deep infilterating endometriosis
Infertility
Exclusion criteria:
Hypersensitivity to dinogest or Gnrh_agonist
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Age
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From 20 years old to 42 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
104
Actual sample size reached:
104
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-11-28, 1400/09/07
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1400.964
Health conditions studied
1
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Description of health condition studied
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Endometriosis
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ICD-10 code
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N97.8
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ICD-10 code description
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Female infertility of other origin
Primary outcomes
1
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Description
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Evaluation of dysmenorrhoea &dysparunia and Dyschezia
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Timepoint
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Thre months adter surgery
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Method of measurement
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Questionnaire for female sexual function index and Questionnaire for visual acuity scale
2
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Description
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Chemical pregnancy
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Timepoint
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Two weeks after embryo transfer
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Method of measurement
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Positive BhCG
Secondary outcomes
1
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Description
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Clinical pregnancy
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Timepoint
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Four weeks after embryo transfer
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Method of measurement
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Vaginal ultrasound
Intervention groups
1
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Description
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Intervention group: After laparoscopic surgery for Deep infilterating endometriosis tablet Dienogest 2mg/day for three months willbe used.
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Category
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Treatment - Drugs
2
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Description
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Control group: After laparoscopic surgery for Deep infilterating endometriosis GNRH AGONIST 11.25 will be used for three months .
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available