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Investigating the effect of amino selenium in the treatment of endometriosis

Phase 3
Recruiting
Conditions
Endometriosis.
Endometriosis
Registration Number
IRCT20110606006709N26
Lead Sponsor
Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
66
Inclusion Criteria

Women of reproductive age (15-49 years)
Being literate in reading and writing
Women with primary endometriosis with endometrioma less than 5 cm
Women with symptomatic endometriosis (dysmenorrhoea pain score of 16 or more in the Mous Menstrual Distress Questionnaire)
Married women who are sexually active

Exclusion Criteria

Probability of malignancy based on vaginal ultrasound
Definite need for surgery based on the opinion of obstetrician and gynecologist
Suffering from diseases such as myoma or hyperplasia or polycystic ovary syndrome based on vaginal ultrasound
Daily and regular consumption of supplements containing Amino Selenium during the last three months according to the patient's statement
Suffering from liver and kidney diseases and the need for dialysis
Pregnancy and breastfeeding
Desire to get pregnant in the next trimester
Allergy to Gelofen

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Average endometrioma cyst size. Timepoint: Before the intervention and 3 months after the start of intervention. Method of measurement: Vaginal ultrasound.;Average dysmenorrhea score. Timepoint: Monthly during 3 months (1, 2, 3 months) after the start of the intervention. Method of measurement: Mous Menstrual Distress Questionnaire (MMDQ).
Secondary Outcome Measures
NameTimeMethod
Average dyspareunia score. Timepoint: Monthly during 3 months (1, 2, 3 months) after the start of the intervention. Method of measurement: Visual analog scale (VAS).;Average score of dysuria. Timepoint: Monthly during 3 months (1, 2, 3 months) after the start of the intervention. Method of measurement: Visual analog scale (VAS).;Average score of Dyschezia. Timepoint: Monthly during 3 months (1, 2, 3 months) after the start of the intervention. Method of measurement: Visual analog scale (VAS).;Average score of non cyclic pain. Timepoint: Monthly during 3 months (1, 2, 3 months) after the start of the intervention. Method of measurement: Visual analog scale (VAS).
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