Polycystic ovary syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Intervention 1: Thirty-six women will receive structured midwifery counseling (four weekly sessions, each lasting 30–45 minutes, conducted via WhatsApp/Google Meet) together with daily oral spermidine
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Women aged 18 to 35 years. Non-pregnant (confirmed by pregnancy test if needed). Definitive diagnosis of polycystic ovary syndrome (PCOS) based on Rotterdam criteria (at least two of the following: oligo/amenorrhea, clinical or biochemical hyperandrogenism, polycystic ovaries on ultrasound). Ability and willingness to participate in the study and provide informed consent.
Exclusion criteria
Exclusion criteria: Use of hormonal medications or supplements affecting hormones in the past three months alongside routine treatment. History of psychiatric consultation or use of psychiatric medications. Presence of ovarian tumors or adrenal disorders. Structural abnormalities of the reproductive system. Participation in educational classes or similar interventions in the past six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Luteinizing Hormone Levels: Changes in serum Luteinizing Hormone levels as a result of the intervention, reflecting alterations in hormonal balance in women with polycystic ovary syndrome. This variable is a key indicator of the intervention’s effect on reproductive hormone regulation, and the sample size is based on its expected change. Timepoint: Measured before the intervention (baseline) and at 12 weeks after the start of the intervention. Method of measurement: Serum Luteinizing Hormone levels will be measured using the Enzyme-Linked Immunosorbent Assay method with a diagnostic kit from Pars Azmoon Company, following the manufacturer’s protocol, with blood samples collected in the morning (7–9 AM) on days 3–5 of the menstrual cycle.;Changes in serum Follicle-Stimulating Hormone levels as a result of the intervention, indicating modifications in hormonal balance in women with polycystic ovary syndrome. This variable is a primary measure of the intervention’s impact, and the sample size is based on its expected change. Timepoint: Measured before the intervention (baseline) and at 12 weeks after the start of the intervention. Method of measurement: Serum Follicle-Stimulating Hormone levels will be measured using the Enzyme-Linked Immunosorbent Assay method with a diagnostic kit from Pars Azmoon Company, following the manufacturer’s protocol, with blood samples collected in the morning (7–9 AM) on days 3–5 of the menstrual cycle.;Changes in serum Testosterone levels as a result of the intervention, reflecting alterations in hyperandrogenism in women with polycystic ovary syndrome. This variable is a key measure of the intervention’s effect, and the sample size is based on its expected change. Timepoint: Measured before the intervention (baseline) and at 12 weeks after the start of the intervention. Method of measurement: Serum Testosterone levels will be measured using the Radioimmunoassay method with a diagnostic kit from Pars Azmoon Company, following the m | — |
Secondary
| Measure | Time frame |
|---|---|
| Menstrual Cycle Regularity and Ovarian Function: Improvement in menstrual cycle regularity and ovarian function in women with polycystic ovary syndrome as a result of the intervention. This variable assesses the intervention’s effect on restoring normal menstrual cycles and ovarian morphology, measured by cycle length and ultrasound findings. Timepoint: Measured before the intervention (baseline) and 12 weeks after the start of the intervention. Method of measurement: Menstrual cycle regularity will be assessed by participant-recorded menstrual cycle length using a calendar (paper or application-based). Ovarian function will be evaluated through transvaginal ultrasound performed by a certified sonologist on day 3 of the menstrual cycle, measuring the number of follicles and ovarian size, with data recorded in a standardized checklist.;Changes in lipid profile, including cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides, in women with polycystic ovary syndrome as a result of the intervention. This variable evaluates the intervention’s impact on metabolic health. Timepoint: Measured before the intervention (baseline) and 12 weeks after the start of the intervention. Method of measurement: Lipid profile, including cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides, will be measured using blood tests with diagnostic kits from Pars Azmoon Company, following the manufacturer’s protocol. Blood samples (10 milliliters, venous) will be collected in a fasting state (minimum 8 hours) in the morning (7–9 AM) on days 3–5 of the menstrual cycle, centrifuged at 3200 revolutions per minute at 4 degrees Celsius for 15 minutes, and stored at -80 degrees Celsius until analysis.;Changes in inflammatory markers, specifically C-reactive protein, in women with polycystic ovary syndrome as a result of the intervention. This variable assesses the intervention’s effect on systemic inflammation. Timepoint: Measured before the inte | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Bakouei
Babol University of Medical Sciences
Outcome results
None listed