Comparing the Effect of Clove Oil and Oral Contraceptive LD on Improvement of Clinical and Paraclinical Parameters of Polycystic Ovarian Syndrome

Phase 3

• Conditions: Polycystic Ovarian Syndrome.; Polycystic ovarian syndrome; E28.2

• Registration Number: IRCT20131009014957N14
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

The diagnosis of PCOS according to the Rotterdam criteria
Age 18 to 45 years
Being literate
BMI between 18.5 and 30
Not using hormonal contraceptives or any other type of hormonal medication currently and during the last three months

Exclusion Criteria

Relative and absolute contraindications of LD pills (having blood pressure above 140/90, smoking and alcohol consumption, pregnancy or breastfeeding, alcohol consumption, smoking, suspicion of breast cancer, coronary heart disease, endometrial carcinoma, etc.)
Women suffering from amenorrhea
Women undergoing infertility treatment at the time of study
Previous surgery on one or both ovaries
Allergy to clove oil
Disorders that cause hyperandrogenism (having Cushing's syndrome, adrenal hyperplasia, androgen-producing tumors, etc.)
Thyroid disorders

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The serum levels of dehidroepyandrosteron(DHEA) and total testosterone. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: By the ELISA method using the relevant kits.;Hirsutism score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using the Ferriman–Gallwey scoring system.

Secondary Outcome Measures

Name	Time	Method
The normalization of menstrual cycles. Timepoint: At the beginning of the study and in each 28-day cycle for 3 cycles during the intervention. Method of measurement: Using the menstrual disorders questionnaire.;The serum levels of fasting Blood glucose and insulin. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: By spectrophotometry and ELISA method.;The serum levels of gonadotropins (FSH and LH). Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: By ELISA method using the relevant kits.;Anthropometric indices (waist circumference, hip circumference, body bass index). Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using anthropometric tools.;Quality of life score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using the health-related quality of life questionnaire of women with polycystic syndrome made by Cronin et al.