Comparison of the effect of metformin and alpha-lipoic acid on hormonal and blood lab tests in patients with polycystic ovary syndrome

Comparison of the Effect of Metformin and Alpha-Lipoic Acid on Hormonal and Blood Parameters in Different PCOS Phenotypes

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240908062973N3

Enrollment

200

Registered

2024-10-24

Start date

2024-10-06

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Patients with polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group1: 100 patients will receive 10 mg of medroxyprogesterone Produced by Iran Hormon Pharmaceutical Company for 14 days along with 2000 mg of metformin produced by Kimid

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: From every race and ethnicity Ages 18-40 Diagnosed with Polycystic Ovary Syndrome (PCOS) (according to the Rotterdam criteria: must have at least two out of three characteristics: clinical or laboratory hyperandrogenism, oligo-ovulation, and the presence of multiple ovarian cysts (PCOM) in the absence of other causes of elevated androgens, ruling out other diseases with similar symptoms)

Exclusion criteria

Exclusion criteria: No presence of chronic metabolic and non-metabolic diseases affecting the diet, such as diabetes, hypothyroidism, hyperthyroidism, high cholesterol, etc. No use of any medications that may interfere with metformin and alpha-lipoic acid and cause drug-related side effects. No adherence to a specific diet for any reason. No pregnancy or decision to become pregnant for at least 4 months of the treatment period.

Design outcomes

Primary

Measure	Time frame
Improvement in hormonal parameter such as AMH. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as FBS. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as TG. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as CHOL. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as LDL. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as HDL. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.	—

Measure

Time frame

Improvement in hormonal parameter such as AMH. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as FBS. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as TG. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as CHOL. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as LDL. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.;Improvement blood parameters such as HDL. Timepoint: 8 weeks after taking the medication. Method of measurement: Laboratory blood sample.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamaneh Rokhgireh

Iran University of Medical Sciences

Rokhgireh.s@iums.ac.ir+98 21 6650 9283

Outcome results

None listed

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