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Investigating the effect of melatonin on polycystic ovary syndrome

The effect of melatonin supplementation on the improvement of menstrual parameters in women with polycystic ovary syndrome: a randomized, double-blind trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220704055367N5
Enrollment
124
Registered
2024-10-13
Start date
2024-11-06
Completion date
Unknown
Last updated
2025-08-19

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

Conditions

?????? ?????? ??? ??????. Polycystic ovarian syndrome

Interventions

Intervention 1: Routine treatment (OCP pill (preferably Desoceptive) one pill per day for 21 days, then 7 days break and start the next pack again) + melatonin 5 mg/day twice for 12 weeks before going

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women with PCOs according to the Rotterdam criteria willing to participate in the intervention

Exclusion criteria

Exclusion criteria: systemic disease (such as diabetes mellitus, Cushing's syndrome, congenital adrenal hyperplasia, hyperprolactinemia and hyperthyroidism) pregnancy miscarriage or delivery within the last 6 weeks breastfeeding in the first 6 months use of hormonal drugs in the last month sleep disorders family history of breast and ovarian cancer having the intention of pregnancy need for surgery and other interventions personal request of the patient

Design outcomes

Primary

MeasureTime frame
Menstrual disorders associated with polycystic ovary syndrome (menstrual disorders including amenorrhea, oligomenorrhea, menstrual bleeding according to Higham's chart). Timepoint: 0, 6 weeks, 12 weeks. Method of measurement: Menstrual irregularities, including amenorrhea, oligomenorrhea, by asking the person and the amount of menstrual bleeding based on Higham's chart.

Secondary

MeasureTime frame
Hormonal profile. Timepoint: 0, 12 weeks. Method of measurement: laboratory evaluation.;Ovarian sonographic findings. Timepoint: 0, 12 weeks. Method of measurement: ultrasonography.;Anthropometric parameters. Timepoint: 0, 12 weeks. Method of measurement: Weight with calibrated scales, abdominal circumference in meters, body mass index with weight squared.;Hirsutism. Timepoint: 0, 12 weeks. Method of measurement: clinical evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Abdi

Iran University of Medical Sciences

fatemeh.abdi87@yahoo.com+98 21 86701

Outcome results

None listed

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