Polycystic Ovary SyndromeIALANCT04881851
Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment
A study testing Inositol + alpha lipoic acid and Inositol in people with Polycystic Ovary Syndrome, run by Universita di Verona at 1 site in Italy.
Trial summary
The aim of this double-blinded, three-armed randomized controlled trial (RCT) is to evaluate the effects of a 6 months treatment with inositol alone or inositol associated with alpha-lipoic acid in women with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Inositol + alpha lipoic acid and Inositol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteItaly
- Study dates
- 7 May 2015to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female subjects
- age between 18 and 40 years old
- diagnosed with PCOS (according to the Rotterdam criteria)
- not use of possible interfering drugs in the 4 previous months
- written informed consent.
Who cannot join
- BMI ≥ 35 kg/m2
- acute illnesses
- chronic kidney or hepatic disease
- pregnant
- taking possible interfering drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site
Endocrinology, Diabetes and Metabolism Section, Department of Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata of Verona
Verona, 37126
About this study
The aim of this double-blinded, three-armed randomized controlled trial (RCT) is to evaluate the effects of a 6 months treatment with inositol alone or inositol associated with alpha-lipoic acid in women with polycystic ovary syndrome (PCOS).
The study population is composed of 90 women with PCOS (diagnosed according to the Rotterdam criteria). Subjects are randomized to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone).
Read more
At recruitment and after 6 months of treatment, the following data are collected:
- clinical data: height, weight, BMI, waist and hip circumference, blood pressure, Ferriman Gallwey Score, menstrual diary
- endocrine parameters (serum total and free testosterone levels, SHBG levels)
- metabolic profile: glycemia and insulinemia at fasting and after oral glucose tolerance test (OGTT), serum lipids
- insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp and surrogate indexes
- ovarian ultrasound data. Furthermore, ovulation is evaluated from the 2nd to the 6th month of the study through progesterone serial dosages on weekly urinary samples.
The primary outcome of the study is the serum free testosterone variation after 6 months of treatment. Secondary outcomes are the variations of lipid profile, ovarian morphology and insulin-sensitivity after 6 months and the number of ovulations occurring in the last 4 months of treatment.
Read the detailed description
The aim of this study is to evaluate the effects of a 6 months treatment with inositol, alone or associated with alpha-lipoic acid, in women with PCOS. This is a double blinded, three-armed RCT.
The study population is composed of 90 women with PCOS, recruited at the Department of Endocrinology and Metabolic Disease of Azienda Ospedaliera Universitaria Integrata (AOUI), Verona.
After recruitment, subjects are randomly assigned to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone). Randomisation is stratified by BMI category (3 categories 18<BMI<25, 25≥BMI<30, 30≥BMI<35 Kg/m2); randomisation list is generated by the statistical software Stata 13.1.
At baseline and after 6 months of treatment, the following data are collected:
- clinical examination: family and personal medical history, menstrual diary, physical examination including height, weight, waist and hip circumferences, blood pressure and hirsutism score (modified Ferriman-Gallwey score)
- total and free testosterone and sex hormone binding globulin (SHBG) blood levels, evaluated in the early follicular phase or after 3 months of amenorrhea
- metabolic profile: glycemia and insulinemia at fasting and after 2h OGTT, serum lipids (total cholesterol, HDL-cholesterol and triglycerides). Glycemia and insulinemia values during OGTT will be used to calculate surrogate indexes of insulin resistance
- insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp technique. Data obtained with this test will be normalized for lean mass, measured by bioelectrical impedance. The hyperinsulinemic-euglycemic clamp is repeated after 6 months of treatment only in subjects who are insulin-resistant at baseline (M-value < 8.6 mg/kg min).
- Chronic inflammation markers (CRP)
- Ovarian ultrasound evaluation, including measurement of the 3 diameters for ovarian volume calculation, and follicle count. The ultrasound examination will be executed by a gynaecologist at the Department of Gynaecology and Obstetrics at AOUI, Verona.
Furthermore, all the study participants are subjected to:
- ovulation assessment by serial progesterone dosages on weekly urinary samples. Patients are given numbered urine beakers and are instructed to collect night urine weekly, starting at the 3rd month of treatment and until the end of the study (17 samples).
- monitoring visits after 2 and 4 months of treatment, to evaluate therapy compliance and possible adverse events. 30 ml blood samples of the study participants will be preserved for 10 years. On these samples, further examinations will be considered if new important markers of PCOS will emerge in the future.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Inositol + alpha lipoic acid, Inositol, Folic acid (placebo comparator)
- Keywords
- Inositol, alpha-lipoic acid
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inositol + alpha lipoic acidDietary supplement
Inositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
InositolDietary supplement
Inositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
Folic acid (placebo comparator)Dietary supplement
Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
| Study group | Role | What they receive |
|---|---|---|
| Inositol + alpha lipoic acid | Experimental | Inositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner Receives: Dietary Supplement: Inositol + alpha lipoic acid |
| Inositol | Experimental | Inositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner Receives: Dietary Supplement: Inositol |
| Folic acid | Placebo comparator | Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner Receives: Dietary Supplement: Folic acid (placebo comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free testosterone variation
Free testosterone variation after 6 months of treatment
Measured: 6 months
Secondary outcomes (4)
Insulin sensitivity variation
Insulin sensitivity variation after 6 months of treatment, evaluated by surrogate indexes in all the subjects and by repeating hyperinsulinemic euglycemic clamp after 6 months of treatment in women that are insulin-resistant at baseline
Measured: 6 months
Lipid profile variation
Lipid profile variation after 6 months of treatment
Measured: 6 months
Ovarian morphology variation
Ovarian morphology variation after 6 months of treatment
Measured: 6 months
Number of ovulations in the last 4 months of treatment
Number of ovulations in the last 4 months of treatment
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start7 May 2015
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: Study treatment products expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, three-armed RCT
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Laborest Italia SPA
- Responsible party
- Principal investigator, Paolo Moghetti, Universita di Verona
- Investigators
- Paolo Moghetti, Professor, Principal investigator, Università degli studi di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881851
- Sponsor's protocol ID
- CE10403
- Acronym
- IALA
- Status last verified
- Apr 2025
- First submitted
- 5 May 2021
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in publications will be shared
Publications
Franks S. Polycystic ovary syndrome. N Engl J Med. 1995 Sep 28;333(13):853-61. doi: 10.1056/NEJM199509283331307. No abstract available.
PubMed 7651477Dunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997 Dec;18(6):774-800. doi: 10.1210/edrv.18.6.0318.
PubMed 9408743Baptiste CG, Battista MC, Trottier A, Baillargeon JP. Insulin and hyperandrogenism in women with polycystic ovary syndrome. J Steroid Biochem Mol Biol. 2010 Oct;122(1-3):42-52. doi: 10.1016/j.jsbmb.2009.12.010. Epub 2009 Dec 28.
PubMed 20036327De Leo V, la Marca A, Petraglia F. Insulin-lowering agents in the management of polycystic ovary syndrome. Endocr Rev. 2003 Oct;24(5):633-67. doi: 10.1210/er.2002-0015.
PubMed 14570747Nestler JE, Jakubowicz DJ, Evans WS, Pasquali R. Effects of metformin on spontaneous and clomiphene-induced ovulation in the polycystic ovary syndrome. N Engl J Med. 1998 Jun 25;338(26):1876-80. doi: 10.1056/NEJM199806253382603.
PubMed 9637806Moghetti P, Castello R, Negri C, Tosi F, Perrone F, Caputo M, Zanolin E, Muggeo M. Metformin effects on clinical features, endocrine and metabolic profiles, and insulin sensitivity in polycystic ovary syndrome: a randomized, double-blind, placebo-controlled 6-month trial, followed by open, long-term clinical evaluation. J Clin Endocrinol Metab. 2000 Jan;85(1):139-46. doi: 10.1210/jcem.85.1.6293.
PubMed 10634377Fleming R, Hopkinson ZE, Wallace AM, Greer IA, Sattar N. Ovarian function and metabolic factors in women with oligomenorrhea treated with metformin in a randomized double blind placebo-controlled trial. J Clin Endocrinol Metab. 2002 Feb;87(2):569-74. doi: 10.1210/jcem.87.2.8261.
PubMed 11836287Azziz R, Ehrmann D, Legro RS, Whitcomb RW, Hanley R, Fereshetian AG, O'Keefe M, Ghazzi MN; PCOS/Troglitazone Study Group. Troglitazone improves ovulation and hirsutism in the polycystic ovary syndrome: a multicenter, double blind, placebo-controlled trial. J Clin Endocrinol Metab. 2001 Apr;86(4):1626-32. doi: 10.1210/jcem.86.4.7375.
PubMed 11297595Tang T, Lord JM, Norman RJ, Yasmin E, Balen AH. Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility. Cochrane Database Syst Rev. 2012 May 16;(5):CD003053. doi: 10.1002/14651858.CD003053.pub5.
PubMed 22592687Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.
PubMed 18308833Barua S, Kuizon S, Junaid MA. Folic acid supplementation in pregnancy and implications in health and disease. J Biomed Sci. 2014 Aug 19;21(1):77. doi: 10.1186/s12929-014-0077-z.
PubMed 25135350Saltiel AR. Second messengers of insulin action. Diabetes Care. 1990 Mar;13(3):244-56. doi: 10.2337/diacare.13.3.244.
PubMed 2137771Baillargeon JP, Diamanti-Kandarakis E, Ostlund RE Jr, Apridonidze T, Iuorno MJ, Nestler JE. Altered D-chiro-inositol urinary clearance in women with polycystic ovary syndrome. Diabetes Care. 2006 Feb;29(2):300-5. doi: 10.2337/diacare.29.02.06.dc05-1070.
PubMed 16443877Fenkci V, Fenkci S, Yilmazer M, Serteser M. Decreased total antioxidant status and increased oxidative stress in women with polycystic ovary syndrome may contribute to the risk of cardiovascular disease. Fertil Steril. 2003 Jul;80(1):123-7. doi: 10.1016/s0015-0282(03)00571-5.
PubMed 12849813Giordano D, Corrado F, Santamaria A, Quattrone S, Pintaudi B, Di Benedetto A, D'Anna R. Effects of myo-inositol supplementation in postmenopausal women with metabolic syndrome: a perspective, randomized, placebo-controlled study. Menopause. 2011 Jan;18(1):102-4. doi: 10.1097/gme.0b013e3181e8e1b1.
PubMed 20811299
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment
- ClinicalTrials.gov ID
- NCT04881851
- Acronym / sponsor ID
- IALA / CE10403
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Inositol, alpha-lipoic acid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study treatment products expired
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Laborest Italia SPA
- Study start
- 7 May 2015 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 11 May 2021 (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.
The aim of this double-blinded, three-armed randomized controlled trial (RCT) is to evaluate the effects of a 6 months treatment with inositol alone or inositol associated with alpha-lipoic acid in women with polycystic ovary syndrome (PCOS).
The study population is composed of 90 women with PCOS (diagnosed according to the Rotterdam criteria). Subjects are randomized to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone).
At recruitment and after 6 months of treatment, the following data are collected:
- clinical data: height, weight, BMI, waist and hip circumference, blood pressure, Ferriman Gallwey Score, menstrual diary
- endocrine parameters (serum total and free testosterone levels, SHBG levels)
- metabolic profile: glycemia and insulinemia at fasting and after oral glucose tolerance test (OGTT), serum lipids
- insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp and surrogate indexes
- ovarian ultrasound data. Furthermore, ovulation is evaluated from the 2nd to the 6th month of the study through progesterone serial dosages on weekly urinary samples.
The primary outcome of the study is the serum free testosterone variation after 6 months of treatment. Secondary outcomes are the variations of lipid profile, ovarian morphology and insulin-sensitivity after 6 months and the number of ovulations occurring in the last 4 months of treatment.
Detailed description
The aim of this study is to evaluate the effects of a 6 months treatment with inositol, alone or associated with alpha-lipoic acid, in women with PCOS. This is a double blinded, three-armed RCT.
The study population is composed of 90 women with PCOS, recruited at the Department of Endocrinology and Metabolic Disease of Azienda Ospedaliera Universitaria Integrata (AOUI), Verona.
After recruitment, subjects are randomly assigned to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone). Randomisation is stratified by BMI category (3 categories 18<BMI<25, 25≥BMI<30, 30≥BMI<35 Kg/m2); randomisation list is generated by the statistical software Stata 13.1.
At baseline and after 6 months of treatment, the following data are collected:
- clinical examination: family and personal medical history, menstrual diary, physical examination including height, weight, waist and hip circumferences, blood pressure and hirsutism score (modified Ferriman-Gallwey score)
- total and free testosterone and sex hormone binding globulin (SHBG) blood levels, evaluated in the early follicular phase or after 3 months of amenorrhea
- metabolic profile: glycemia and insulinemia at fasting and after 2h OGTT, serum lipids (total cholesterol, HDL-cholesterol and triglycerides). Glycemia and insulinemia values during OGTT will be used to calculate surrogate indexes of insulin resistance
- insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp technique. Data obtained with this test will be normalized for lean mass, measured by bioelectrical impedance. The hyperinsulinemic-euglycemic clamp is repeated after 6 months of treatment only in subjects who are insulin-resistant at baseline (M-value < 8.6 mg/kg min).
- Chronic inflammation markers (CRP)
- Ovarian ultrasound evaluation, including measurement of the 3 diameters for ovarian volume calculation, and follicle count. The ultrasound examination will be executed by a gynaecologist at the Department of Gynaecology and Obstetrics at AOUI, Verona.
Furthermore, all the study participants are subjected to:
- ovulation assessment by serial progesterone dosages on weekly urinary samples. Patients are given numbered urine beakers and are instructed to collect night urine weekly, starting at the 3rd month of treatment and until the end of the study (17 samples).
- monitoring visits after 2 and 4 months of treatment, to evaluate therapy compliance and possible adverse events. 30 ml blood samples of the study participants will be preserved for 10 years. On these samples, further examinations will be considered if new important markers of PCOS will emerge in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Double blinded, three-armed RCT
| Arm | Type | Receives |
|---|---|---|
| Inositol + alpha lipoic acid | Experimental | Dietary Supplement: Inositol + alpha lipoic acidInositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner |
| Inositol | Experimental | Dietary Supplement: InositolInositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner |
| Folic acid | Placebo comparator | Dietary Supplement: Folic acid (placebo comparator)Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female subjects
- age between 18 and 40 years old
- diagnosed with PCOS (according to the Rotterdam criteria)
- not use of possible interfering drugs in the 4 previous months
- written informed consent.
Key exclusion criteria (5 listed)
- BMI ≥ 35 kg/m2
- acute illnesses
- chronic kidney or hepatic disease
- pregnant
- taking possible interfering drugs
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 |
|---|---|---|
| Inositol + alpha lipoic acidInositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner | Dietary supplement | Inositol + alpha lipoic acid |
| InositolInositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner | Dietary supplement | Inositol |
| Folic acid (placebo comparator)Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner | Dietary supplement | Folic acid |
Primary outcome
Free testosterone variation
Time frame: 6 months
Free testosterone variation after 6 months of treatment
4 secondary outcomes
Insulin sensitivity variation
Time frame: 6 months
Lipid profile variation
Time frame: 6 months
Ovarian morphology variation
Time frame: 6 months
Number of ovulations in the last 4 months of treatment
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Study treatment products expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 7651477Franks S. Polycystic ovary syndrome. N Engl J Med. 1995 Sep 28;333(13):853-61. doi: 10.1056/NEJM199509283331307. No abstract available.
- Background: PubMed 9408743Dunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997 Dec;18(6):774-800. doi: 10.1210/edrv.18.6.0318.
- Background: PubMed 20036327Baptiste CG, Battista MC, Trottier A, Baillargeon JP. Insulin and hyperandrogenism in women with polycystic ovary syndrome. J Steroid Biochem Mol Biol. 2010 Oct;122(1-3):42-52. doi: 10.1016/j.jsbmb.2009.12.010. Epub 2009 Dec 28.
- Background: PubMed 14570747De Leo V, la Marca A, Petraglia F. Insulin-lowering agents in the management of polycystic ovary syndrome. Endocr Rev. 2003 Oct;24(5):633-67. doi: 10.1210/er.2002-0015.
- Background: PubMed 9637806Nestler JE, Jakubowicz DJ, Evans WS, Pasquali R. Effects of metformin on spontaneous and clomiphene-induced ovulation in the polycystic ovary syndrome. N Engl J Med. 1998 Jun 25;338(26):1876-80. doi: 10.1056/NEJM199806253382603.
- Background: PubMed 10634377Moghetti P, Castello R, Negri C, Tosi F, Perrone F, Caputo M, Zanolin E, Muggeo M. Metformin effects on clinical features, endocrine and metabolic profiles, and insulin sensitivity in polycystic ovary syndrome: a randomized, double-blind, placebo-controlled 6-month trial, followed by open, long-term clinical evaluation. J Clin Endocrinol Metab. 2000 Jan;85(1):139-46. doi: 10.1210/jcem.85.1.6293.
- Background: PubMed 11836287Fleming R, Hopkinson ZE, Wallace AM, Greer IA, Sattar N. Ovarian function and metabolic factors in women with oligomenorrhea treated with metformin in a randomized double blind placebo-controlled trial. J Clin Endocrinol Metab. 2002 Feb;87(2):569-74. doi: 10.1210/jcem.87.2.8261.
- Background: PubMed 11297595Azziz R, Ehrmann D, Legro RS, Whitcomb RW, Hanley R, Fereshetian AG, O'Keefe M, Ghazzi MN; PCOS/Troglitazone Study Group. Troglitazone improves ovulation and hirsutism in the polycystic ovary syndrome: a multicenter, double blind, placebo-controlled trial. J Clin Endocrinol Metab. 2001 Apr;86(4):1626-32. doi: 10.1210/jcem.86.4.7375.
- Background: PubMed 22592687Tang T, Lord JM, Norman RJ, Yasmin E, Balen AH. Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility. Cochrane Database Syst Rev. 2012 May 16;(5):CD003053. doi: 10.1002/14651858.CD003053.pub5.
- Background: PubMed 18308833Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.
- Background: PubMed 25135350Barua S, Kuizon S, Junaid MA. Folic acid supplementation in pregnancy and implications in health and disease. J Biomed Sci. 2014 Aug 19;21(1):77. doi: 10.1186/s12929-014-0077-z.
- Background: PubMed 2137771Saltiel AR. Second messengers of insulin action. Diabetes Care. 1990 Mar;13(3):244-56. doi: 10.2337/diacare.13.3.244.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in publications will be shared
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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. This study is not recruiting at the moment.
Paolo Moghetti, Professor principal investigator
Università degli studi di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inositol + alpha lipoic acid and Inositol in people with Polycystic Ovary Syndrome, run by Universita di Verona at 1 site in Italy.
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: stopped early, as of the sponsor's last update on 16 Apr 2025. 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 Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study treatment products expired). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free testosterone variation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04881851, which also lists 33 linked publications.
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 16 Apr 2025.