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

Clinical trial of the effect of melatonin supplementation compared with the placebo on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in women with polycystic ovary syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017082733941N9

Enrollment

Registered

2017-09-18

Start date

2017-08-15

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, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally. Intervention 2: Control group: Placebo capsule (Barij

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 Breastfeeding Patients with sleeping disorders Adrenal hyperplasia Androgen-secreting tumors Hyperprolactinemia Thyroid dysfunction and/or diabetes

Design outcomes

Primary

Measure	Time frame
Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.	—

Secondary

Measure	Time frame
Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total testosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;SHBG. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of TGFB gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of VEGF gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Modified Ferriman Gallwey. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questioner.	—

Measure

Time frame

Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total testosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;SHBG. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of TGFB gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of VEGF gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Modified Ferriman Gallwey. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questioner.

—

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 21, 2026