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Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients

ConditionPoly Cystic Ovary Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age21-40
SponsorBeni-Suef University

About this trial

This study evaluates the efficacy of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS). The study also assesses metabolic, hormonal, and clinical outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 21 to 40 years

Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria

Not currently pregnant or lactating

No hormonal therapy within the last 3 months

Disqualifiers

- History of diabetes mellitus, hypertension, or thyroid disorders

History of cardiovascular, renal, or hepatic disease

Use of hormonal contraceptives or insulin sensitizers within the last 3 months

Known hypersensitivity or allergy to study medications (myo-inositol, alpha-lipoic acid, or metformin)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Myo-inositol

    Drug

    Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.

  • Folic Acid

    Dietary supplement

    Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.

  • Alpha Lipoic Acid

    Drug

    Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.

  • Metfomin

    Drug

    Metformin administered orally starting at 500 mg once daily and titrated over two weeks to a maximum dose of 1500 mg/day (500 mg three times daily), taken after meals for 6 months.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Myo-Inositol + Folic AcidExperimental treatment 2 interventions
Group B: Myo-Inositol + Folic Acid + Alpha-Lipoic AcidExperimental treatment 3 interventions
Group C: Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + MetforminExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Ovulation Rate

Ovulation confirmed by mid-luteal serum progesterone level greater than 3 ng/mL or ultrasound-confirmed follicular rupture.

Time frame
From baseline to 6 months
2

Menstrual Cycle Regularity

Proportion of participants achieving menstrual cycle regularity, defined as cycle length between 21 and 35 days for at least two consecutive cycles during the study period.

Time frame
From baseline to 6 months

Secondary outcomes

1

Serum Prolactin Levels

Change in serum prolactin levels measured in ng/mL using standard laboratory assays.

Time frame
Baseline, 3 months, and 6 months
2

Body Mass Index (BMI)

Change in body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).

Time frame
Baseline, 3 months, and 6 months
3

Serum Triglycerides

Change in fasting serum triglyceride levels measured in mg/dL.

Time frame
Baseline, 3 months, and 6 months
4

Low-Density Lipoprotein (LDL) Cholesterol

Change in serum LDL cholesterol levels measured in mg/dL.

Time frame
Baseline, 3 months, and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov
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