Effect of melatonin supplementation in treatment of patients with polycystic ovary syndrome

Clinical trial of the effect of melatonin supplementation compared with the placebo on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017090533941N23

Enrollment

Registered

2017-11-14

Start date

2017-10-30

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: Melatonin supplements (Zahravi Pharmaceutical Company, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally. Intervention 2: Control group:

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years

Exclusion criteria

Exclusion criteria: Pregnancy Adrenal hyperplasia Androgen-secreting tumors Hyperprolactinemia Thyroid dysfunction Diabetes and other metabolic disorders at enrollment Inflammatory and malignant diseases, Taking melatonin supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment The night shift workers

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.	—

Secondary

Measure	Time frame
Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of GLUT-1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of LDLR gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.	—

Measure

Time frame

Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of GLUT-1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of LDLR gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

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