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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230427058010N1
Enrollment
128
Registered
2024-03-11
Start date
2024-03-18
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: First intervention group: sildenafil (25 mg sildenafil citrate orally every 6 hours) + metformin tablets (500 mg three times a day orally). Intervention 2: second intervention group: m

Sponsors

Emam Sajad Yasouj Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Asadi kalmeh

Emam Sajad Yasouj Hospital

Zasadik66@gmail.com+98 74 3322 0165

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026