Effect of supplementation in treatment of women with polycystic ovary syndrome

Clinical trial of the effect of soy isoflavone supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201601025623N62

Enrollment

Registered

2016-01-12

Start date

2015-11-12

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: Soy isoflavone capsule, 45 mg, daily for 12 weeks orally. Intervention 2: Control group: Placebo capsule, daily for 12 weeks orally.

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with PCOS according to Rotterdam criteria Aged 18 to 40 years

Exclusion criteria

Exclusion criteria: Pregnant women Elevated levels of prolactin Thyroid disorder Endocrine diseases including diabetes or impaired glucose tolerance, and gastrointestinal problems

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: Questionnaire.;Testosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.	—

Secondary

Measure	Time frame
Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Follicular-stimulating hormone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;LDL-cholesterol. 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.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Follicular-stimulating hormone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;LDL-cholesterol. 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.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

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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