Comparing the effect of nettle extract with COCs on the improvement of clinical and paraclinical symptoms of polycystic ovary syndrome.

Phase 3

Recruiting

• Conditions: Clinical and paraclinical symptoms of polycystic ovary syndrome.; Polycystic ovarian syndrome; E28.2

• Registration Number: IRCT20110606006709N25
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Confirming the diagnosis of PCOS according to the Rotterdam criteria (clinical or biochemical hyperandrogenism, menstrual cycle disorders or polycystic ovary ultrasound signs)
Age 18 to 40 years
Being literate in reading and writing
BMI between 18.5 and 30
Not using hormonal contraceptives or any other type of hormonal medication currently and during the last three months
Not wanting to get pregnant

Exclusion Criteria

Relative and absolute contraindications of LD tablets (having blood pressure above 14/9, smoking and alcohol use, pregnancy or breastfeeding, alcohol and smoking use, suspicion of breast cancer, coronary heart disease, endometrial carcinoma, etc.)
Women undergoing infertility treatment at the time of study.
Previous surgery on one or both ovaries.
Allergy to nettle
Disorders that cause hyperandrogenism (having Cushing's syndrome, adrenal hyperplasia, androgen-producing tumors, etc.)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum levels of DHEA and total testosterone. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: By ELISA method in the central laboratory.;Average score of hirsutism. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Ferriman–Gallwey scale.

Secondary Outcome Measures

Name	Time	Method
ormalization of menstrual cycles. Timepoint: Before the intervention, one month, two months, and three months after the intervention. Method of measurement: Questionnaire made by the researcher and Higham's chart.;Serum level of fasting blood sugar. Timepoint: Before the start of the intervention and and 3 months after the intervention. Method of measurement: By spectrophotometric method in the central laboratory.;Serum levels of gonadotropins (FSH and LH). Timepoint: Before the start of the intervention and and 3 months after the intervention. Method of measurement: By ELISA method in the central laboratory.