Poly Cystic Ovary SyndromePhase 3ALA-MYO-PCOSNCT07630779
Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients
A Phase 3 study testing Myo-inositol, Folic Acid and Alpha Lipoic Acid in people with Poly Cystic Ovary Syndrome, run by Beni-Suef University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Poly Cystic Ovary Syndrome
- What is being tested?
- Myo-inositol, Folic Acid and Alpha Lipoic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2026to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Willing and able to provide informed consent
Who cannot join
- - 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)
- Non-Egyptian ethnicity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate
Hesham ElShaer, Professor, +0201223130881, dr.heshamelshaer@hotmail.com
About this study
Official title: A Randomized Controlled Trial Evaluating the Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol With or Without Metformin in Non-Diabetic Women With Polycystic Ovary Syndrome
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.
Read the detailed description
This is a prospective randomized controlled parallel-group clinical trial evaluating the effects of alpha-lipoic acid combined with myo-inositol, with or without metformin, in women with polycystic ovary syndrome (PCOS).
A total of 180 patients will be randomized into three groups:
Myo-inositol with folic acid Myo-inositol + alpha-lipoic acid Myo-inositol + alpha-lipoic acid + metformin
The study duration is 6 months. Outcomes include menstrual regularity, ovulation rate, hormonal parameters, metabolic markers, and clinical signs of hyperandrogenism.
- Conditions
- Poly Cystic Ovary Syndrome
- Being tested
- Myo-inositol, Folic Acid, Alpha Lipoic Acid, Metfomin
- Keywords
- PCOS Myo-Inositol Alpha Lipoic Acid Metformin Insulin Resistance Ovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDrug
Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.
Folic AcidDietary supplement
Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.
Alpha Lipoic AcidDrug
Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.
MetfominDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Myo-Inositol + Folic Acid | Experimental | Participants receive myo-inositol 2 g twice daily combined with folic acid 200 µg twice daily for 6 months. Receives: Drug: Myo-inositol; Dietary Supplement: Folic Acid |
| Myo-Inositol + Folic Acid + Alpha-Lipoic Acid | Experimental | Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily for 6 months. Receives: Drug: Myo-inositol; Dietary Supplement: Folic Acid; Drug: Alpha Lipoic Acid |
| Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin | Experimental | Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily and metformin titrated up to 1500 mg/day over 2 weeks for 6 months. Receives: Drug: Myo-inositol; Dietary Supplement: Folic Acid; Drug: Alpha Lipoic Acid; Drug: Metfomin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Rate
Ovulation confirmed by mid-luteal serum progesterone level greater than 3 ng/mL or ultrasound-confirmed follicular rupture.
Measured: From baseline to 6 months
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.
Measured: From baseline to 6 months
Secondary outcomes (10)
Serum Prolactin Levels
Change in serum prolactin levels measured in ng/mL using standard laboratory assays.
Measured: Baseline, 3 months, and 6 months
Body Mass Index (BMI)
Change in body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).
Measured: Baseline, 3 months, and 6 months
Serum Triglycerides
Change in fasting serum triglyceride levels measured in mg/dL.
Measured: Baseline, 3 months, and 6 months
Low-Density Lipoprotein (LDL) Cholesterol
Change in serum LDL cholesterol levels measured in mg/dL.
Measured: Baseline, 3 months, and 6 months
High-Density Lipoprotein (HDL) Cholesterol
Change in serum HDL cholesterol levels measured in mg/dL.
Measured: Baseline, 3 months, and 6 months
Fasting Blood Glucose
Change in fasting blood glucose levels measured in mg/dL after an overnight fast.
Measured: Baseline, 3 months, and 6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Change in insulin resistance calculated using the HOMA-IR index based on fasting glucose and insulin levels.
Measured: Baseline, 3 months, and 6 months
Testosterone
Change in serum testosterone levels measured in ng/dL.
Measured: Baseline, 3 months, and 6 months
Serum Luteinizing Hormone (LH)
Change in serum luteinizing hormone levels measured in mIU/mL using standard laboratory assays.
Measured: Baseline, 3 months, and 6 months
Serum Follicle-Stimulating Hormone (FSH)
Change in serum follicle-stimulating hormone levels measured in mIU/mL using standard laboratory assays.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start10 Mar 2026
- Primary completion10 Sep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poly Cystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelkader, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630779
- Sponsor's protocol ID
- N-52-2026
- Acronym
- ALA-MYO-PCOS
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol With or Without Metformin in Non-Diabetic Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07630779
- Acronym / sponsor ID
- ALA-MYO-PCOS / N-52-2026
- Conditions
- Poly Cystic Ovary Syndrome
- Keywords
- PCOS Myo-Inositol Alpha Lipoic Acid Metformin Insulin Resistance Ovulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective randomized controlled parallel-group clinical trial evaluating the effects of alpha-lipoic acid combined with myo-inositol, with or without metformin, in women with polycystic ovary syndrome (PCOS).
A total of 180 patients will be randomized into three groups:
Myo-inositol with folic acid Myo-inositol + alpha-lipoic acid Myo-inositol + alpha-lipoic acid + metformin
The study duration is 6 months. Outcomes include menstrual regularity, ovulation rate, hormonal parameters, metabolic markers, and clinical signs of hyperandrogenism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myo-Inositol + Folic Acid | Experimental | Drug: Myo-inositol, Dietary Supplement: Folic AcidParticipants receive myo-inositol 2 g twice daily combined with folic acid 200 µg twice daily for 6 months. |
| Myo-Inositol + Folic Acid + Alpha-Lipoic Acid | Experimental | Drug: Myo-inositol, Dietary Supplement: Folic Acid, Drug: Alpha Lipoic AcidParticipants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily for 6 months. |
| Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin | Experimental | Drug: Myo-inositol, Dietary Supplement: Folic Acid, Drug: Alpha Lipoic Acid, Drug: MetfominParticipants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily and metformin titrated up to 1500 mg/day over 2 weeks for 6 months. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Willing and able to provide informed consent
Key exclusion criteria (5 listed)
- - 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)
- Non-Egyptian ethnicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myo-inositolMyo-inositol administered orally at a dose of 2 g twice daily for 6 months. | Drug | Myo-Inositol + Folic Acid, Myo-Inositol + Folic Acid + Alpha-Lipoic Acid, Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin |
| Folic AcidFolic acid administered orally at a dose of 200 micrograms twice daily for 6 months. | Dietary supplement | Myo-Inositol + Folic Acid, Myo-Inositol + Folic Acid + Alpha-Lipoic Acid, Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin |
| Alpha Lipoic AcidAlpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months. | Drug | Myo-Inositol + Folic Acid + Alpha-Lipoic Acid, Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin |
| MetfominMetformin 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. | Drug | Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin |
Primary outcome
Ovulation Rate
Time frame: From baseline to 6 months
Ovulation confirmed by mid-luteal serum progesterone level greater than 3 ng/mL or ultrasound-confirmed follicular rupture.
Menstrual Cycle Regularity
Time frame: From baseline to 6 months
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.
10 secondary outcomes
Serum Prolactin Levels
Time frame: Baseline, 3 months, and 6 months
Body Mass Index (BMI)
Time frame: Baseline, 3 months, and 6 months
Serum Triglycerides
Time frame: Baseline, 3 months, and 6 months
Low-Density Lipoprotein (LDL) Cholesterol
Time frame: Baseline, 3 months, and 6 months
High-Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline, 3 months, and 6 months
Fasting Blood Glucose
Time frame: Baseline, 3 months, and 6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, 3 months, and 6 months
Testosterone
Time frame: Baseline, 3 months, and 6 months
Serum Luteinizing Hormone (LH)
Time frame: Baseline, 3 months, and 6 months
Serum Follicle-Stimulating Hormone (FSH)
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myo-inositol, Folic Acid and Alpha Lipoic Acid in people with Poly Cystic Ovary Syndrome, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Abdelkader, Lecturer Assistant (+201050095206, ahmed.abdelkader@hu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation Rate (time frame: From baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.