Evaluation of the effect of sildenafil plus melatonin on oxidative stress markers in polycystic ovarian syndrome patients who treated with metformi

Phase 3

Recruiting

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

• Registration Number: IRCT20230427058010N1
• Lead Sponsor: Emam Sajad Yasouj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

Patients aged 18 to 45 years
Body mass index 19 to 25
Presence of two of the following cases (according to the Rotterdam criteria): Findings of ultrasound sonography ,which was performed on the 10th day of the patient's last menstrual cycle (ovarian volume more than 10 ml or more than 12 follicles of 2 to 9 mm)
Symptoms of hyperandrogenism: Clinical (hirsutism according to Freeman Galloway criteria more than 7 or acne) ,Laboratory (increasing the total testosterone level more than the standard value determined by the relevant laboratory) Oligomenorrhea (cycles longer than 35 days) or amenorrhea (absence of menstruation in the last 6 months)

Exclusion Criteria

Patients who do not want to cooperate.
Sildenafil sensitivity and intolerance to side effects (flushing, visual disturbances, severe drop in blood pressure and hearing disorders)
Pregnancy
Existence of severe mental conditions since 6 months before the research that has an adverse effect on the patient's quality of life, such as the death of a loved one, incurable illness in family members, change of residence, sudden loss of job or extensive surgery.
Suffering from a severe degree of depression and anxiety according to the depression and anxiety questionnaire based on the Beck depression and anxiety questionnaire
Current use of psychiatric medications
Language or cognitive problems preventing the patient from completing the questionnaire
Smoking

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total plasma antioxidant capacity. Timepoint: 0-3 months. Method of measurement: Ferric Reducing Ability of Plasma.;Metabolites NO. Timepoint: 0-3 months. Method of measurement: Griess method.;Sulfidril protein. Timepoint: 0-3 months. Method of measurement: spectroscopy.;Protein carbonyl. Timepoint: 0-3 months. Method of measurement: spectroscopy.;Malonodialdehyde (MDA). Timepoint: 0-3 months. Method of measurement: spectroscopy.;The inflammatory marker CRP. Timepoint: 0-3 months. Method of measurement: Eliza Sandwich.