PCOSNCT03608813

Myo-inositol, D-chiro-inositol and Glucomannan in PCOS

An observational study of PCOS, run by University of Salerno.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to analyze the metabolic profiles in women with PCOS before and after 3 months of therapy with a combination of myo-inositol, D-chiro-inositol and glucomannan, and compare these data with a group of healthy control women. Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: PCOS
What is being tested?: Serum Metabolomics profiling
How many people: 120 participants
Where: No sites listed yet
Study dates: 10 Sep 2016to 31 Jul 2017
Phase: Observational
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 35 years
Women only
Healthy volunteers accepted
Adult

Study population: Young women with a PCOS diagnosis without intercurrent chronic illness and a matched healthy population.

Who may be able to join

overweight/obesity (BMI > 25 kg/m2);
absence of any other acute intercurrent or chronic illness;
a positive diagnosis of PCOS according to Rotterdam criteria.

Who cannot join

Use of hormonal medications or drugs that affect insulin sensitivity (e.g., inositols or metformin) before enrollment

About this study

Official title: Effects of a Combined Treatment With Myo-inositol, D-chiro-inositol and Glucomannan in Women With PCOS

Read the detailed description

RATIONALE \& BACKGROUND INFORMATION Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome and one of the most common female endocrine disorders, affecting 5-20% of women in reproductive age . Clinical expression is highly variable, but typically includes oligo-ovulation or anovulation, hyperandrogenism and polycystic ovaries . PCOS is associated with an increased risk of type 2 diabetes, cardiovascular events and endometrial cancer. Insulin Resistance (IR) plays a central role in approximately 70-80% of obese women and in 15-30% of lean women with PCOS, and represents the pathogenic link between metabolic and reproductive disorders in PCOS. According to recent guidelines, insulin-sensitizer drugs, like inositols, are the first-line therapy in women with metabolic abnormalities and irregular menstrual cycle with the purpose to improve fertility, whereas a lifestyle change with weight loss and physical activity is the first step in overweight and obese PCOS patients . Moreover, the association inositols-glucomannan may represent a good therapeutic strategy in the treatment of PCOS women with insulin resistance. Metabolomic approach is used to better define the pathophysiology of PCOS and to describe how different therapies can modify metabolic profiles. Although the association inositols-glucomannan may represent a good therapeutic strategy in the treatment of PCOS women with insulin resistance, the effect of inositols on the metabolomic profile of these women has not been described yet.
STUDY GOALDS AND OBJECTIVES The aim of this study is to analyze the metabolic profiles in women with PCOS before and after 3 months of therapy with a combination of myo-inositol, D-chiro-inositol and glucomannan, and compare these data with a group of healthy control women.
STUDY DESIGN The study is a prospective and observation. The inclusion criteria are: age between 18 and 35 years, overweight/obesity (BMI > 25 kg/m2), absence of any other acute intercurrent or chronic illness, a positive diagnosis of PCOS according to Rotterdam criteria. Exclusion criterion is using hormonal medications or drugs that affect insulin sensitivity (e.g., inositols or metformin) before enrollment. The use of myo-inositol (1.75 g), D-chiro-inositol (0.25 g) and glucomannan (4.0 g)/die must precede the recruitment of no more than 30 days. The decision to start treatment must have already been made before and independently of the start of the study. The use of inositol and glucomannan must take place according to the technical data sheet. In particular, myo-inositol (1.75 g), D-chiro-inositol (0.25 g) and glucomannan (4.0 g) are expected to be subdivided into two doses before main meals.
METHODOLOGY 4.1 Admission visit (V0) Once the eligibility criteria have been checked, the investigator will inform the patient about the objectives of the study during the initial visit (V0) and obtain written informed consent form. The compilation of a clinical card includes general information, anamnesis, BMI, the characteristics of the menstrual cycle, the amount of menstrual loss, the degree of hirsutism according to the Ferriman-Gallwey index and the degree of acne in agreement to the Global evaluation scale proposed in 2002 by FDA. The investigator will collect from the clinical documentation available the baseline glycaemia, insulin, triglycerides, cholesterol values before the start of the treatment. Furthermore, information on the ultrasound picture will be collected in terms of ovary volumes and antral follicles. A sample of 2-3 ml of basal blood will be collected for metabolomic evaluations, using a BD vacutainer (Becton Dickinson, Oxfordshire, UK) blood collection red tube (with no additives). After centrifugation, the sample will immediately freeze to -80 °C until the time of analysis. The patient will then be invited to continue treatment with myo-inositol (1.75 g), D-chiro-inositol (0.25 g) and glucomannan (4 g) die and to show up for control after 90 days (V1). 4.2 Follow-up visit 90th day (±15) after enrollment (V1) During the V1 the patient will be interviewed on the regular therapy and clinical symptoms, any adverse events and the course of the menstrual cycle. Furthermore, all patients will be re-evaluated regarding the anthropometric, biochemical and ultrasound parameters. At V1 a second blood sample of 2-3 ml will be collected with the same methods describe above. 4.3 Biochemical and metabolomics samples analysis Blood concentration of glucose, insulin, triglycerides and cholesterol is evaluated for control subjects and for cases at baseline and after 3 months of treatment. HOMA-IR si also calculated. Ovary volumes and the antral follicles count were evaluated by a vaginal ultrasound performed by a trained gynecologist. Metabolome extraction, purification and derivatization is carried out with the MetaboPrep GC kit (Theoreo srl, Montecorvino Pugliano [SA], Italy) according to the manufacturer's instructions. Details regarding metabolite extraction and the overall analytical scheme, including QA/QC sample analyses, were reported in Troisi et al. (2017, 2018)
Follow-Up Three months.
Data Management and Statistical Analysis At the end of the treatments the data collection of all patients is scheduled and the introduction of the same, in coded or clear form, in a database (Excel for windows) appropriately structured to contain all the expected items. In order to comply with the privacy law, the sensitive nominal data will be appropriately replaced by the numerical codes assigned to each patient, so that from the simple consultation of the data it will not be possible to deduce any individual direct reference. Moreover, the only data that can be extracted from the database are related to aggregated sets to be published for scientific purposes. Data is reported as mean±standard deviation for continuous variables and number (percentage) for categorical variables. Statistical analysis are performed using Statistica software (StatSoft, Oklahoma, USA) and Minitab (Minitab Inc, Pennsylvania, USA). Normal distribution of data is verified using the Shapiro-Wilks test. Since the data are normally distributed, the investigators use one-way ANOVA with the Tukey post hoc test for inter-group comparisons. The alpha (ɑ) value is set to 0.05. Pearson's chi-squared test is used to determine differences among groups for the categorical variables. For multivariate data analysis, the chromatographic data are tabulated with one sample per row and one variable (metabolite) per column. Data pre-treatment consists of normalizing each metabolite peak area to that of the internal standard followed by generalized log transformation and data scaling by autoscaling (mean-centered and divide it by standard deviation of each variable). PLS-DA is performed using the statistical software package R (Foundation for Statistical Computing, Vienna, Austria). Class separation is achieved by PLS-DA, which is a supervised method that uses multivariate regression techniques to extract, via linear combinations of original variables (X), the information that can predict class membership (Y). PLS regression is performed using the plsr function included in the R pls package. Classification and cross-validation is performed using the corresponding wrapper function included in the caret package. A permutation test is performed to assess the significance of class discrimination. In each permutation, a PLS-DA model is built between the data (X) and the permuted class labels (Y) using the optimal number of components determined by cross validation for the model based on the original class assignment. Variable Importance in Projection (VIP) scores are calculated for each metabolite. The VIP score is a weighted sum of squares of the PLS loadings, taking into account the amount of explained Y-variation in each dimension. The highest scoring VIP metabolites are compared in terms of fold changes (FC). FC is the ratio of the mean abundances between any two classes and is a measure describing how much a quantity changes going from an initial to a final value. The metabolic pathways are constructed using MetScape application of the software Cytoscape.
Expected Outcomes of the Study The goal of this pilot study is to identify a complex network of serum molecules that appear to be correlated with PCOS, and with a combined treatment with inositols and glucomannan.
Duration of the Project 24 months

Conditions: PCOS
Being tested: Serum Metabolomics profiling
Keywords: Metabolomics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Serum Metabolomics profilingOther
Untargeted serum metabolomics profiling

Study groups in NCT03608813
Study group	Role	What they receive
Controls		Healthy subjects Receives: Other: Serum Metabolomics profiling
Case		PCOS affected subjects Receives: Other: Serum Metabolomics profiling

What is being measured

The primary outcome is the main question the study is designed to answer.

Untargeted serum metabolomics profiling
Identify a complex network of serum molecules that appear to be correlated with PCOS, and with a combined treatment with inositols and glucomannan.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201631 Jul 2017

First posted1 Aug 2018
Study start10 Sep 2016
Primary completion10 Sep 2016
Study completion31 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for PCOSStudies 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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03608813
Sponsor's protocol ID: PCOS-01
Status last verified: Aug 2018
First submitted: 24 Jul 2018
Last updated: 3 Aug 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Azziz R, Carmina E, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Futterweit W, Janssen OE, Legro RS, Norman RJ, Taylor AE, Witchel SF; Task Force on the Phenotype of the Polycystic Ovary Syndrome of The Androgen Excess and PCOS Society. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009 Feb;91(2):456-88. doi: 10.1016/j.fertnstert.2008.06.035. Epub 2008 Oct 23.
PubMed 18950759
Azziz R, Woods KS, Reyna R, Key TJ, Knochenhauer ES, Yildiz BO. The prevalence and features of the polycystic ovary syndrome in an unselected population. J Clin Endocrinol Metab. 2004 Jun;89(6):2745-9. doi: 10.1210/jc.2003-032046.
PubMed 15181052
Fauser BC, Tarlatzis BC, Rebar RW, Legro RS, Balen AH, Lobo R, Carmina E, Chang J, Yildiz BO, Laven JS, Boivin J, Petraglia F, Wijeyeratne CN, Norman RJ, Dunaif A, Franks S, Wild RA, Dumesic D, Barnhart K. Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group. Fertil Steril. 2012 Jan;97(1):28-38.e25. doi: 10.1016/j.fertnstert.2011.09.024. Epub 2011 Dec 6.
PubMed 22153789
Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.
PubMed 14711538
Sortino MA, Salomone S, Carruba MO, Drago F. Polycystic Ovary Syndrome: Insights into the Therapeutic Approach with Inositols. Front Pharmacol. 2017 Jun 8;8:341. doi: 10.3389/fphar.2017.00341. eCollection 2017.
PubMed 28642705
Troisi J, Sarno L, Landolfi A, Scala G, Martinelli P, Venturella R, Di Cello A, Zullo F, Guida M. Metabolomic Signature of Endometrial Cancer. J Proteome Res. 2018 Feb 2;17(2):804-812. doi: 10.1021/acs.jproteome.7b00503. Epub 2018 Jan 2.
PubMed 29235868
Troisi J, Cinque C, Giugliano L, Symes S, Richards S, Adair D, Cavallo P, Sarno L, Scala G, Caiazza M, Guida M. Metabolomic change due to combined treatment with myo-inositol, D-chiro-inositol and glucomannan in polycystic ovarian syndrome patients: a pilot study. J Ovarian Res. 2019 Mar 23;12(1):25. doi: 10.1186/s13048-019-0500-x.
PubMed 30904021

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

All PCOS trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Combined Treatment With Myo-inositol, D-chiro-inositol and Glucomannan in Women With PCOS
ClinicalTrials.gov ID: NCT03608813
Acronym / sponsor ID: PCOS-01
Conditions: PCOS
Keywords: Metabolomics
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University of SalernoUniversity, hospital or other
Collaborators: Theoreo Srl
Study start: 10 Sep 2016 (actual)
Primary completion: 10 Sep 2016 (actual)
Study completion: 31 Jul 2017 (actual)
First posted: 1 Aug 2018 (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.

Detailed description

RATIONALE \& BACKGROUND INFORMATION Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome and one of the most common female endocrine disorders, affecting 5-20% of women in reproductive age . Clinical expression is highly variable, but typically includes oligo-ovulation or anovulation, hyperandrogenism and polycystic ovaries . PCOS is associated with an increased risk of type 2 diabetes, cardiovascular events and endometrial cancer. Insulin Resistance (IR) plays a central role in approximately 70-80% of obese women and in 15-30% of lean women with PCOS, and represents the pathogenic link between metabolic and reproductive disorders in PCOS. According to recent guidelines, insulin-sensitizer drugs, like inositols, are the first-line therapy in women with metabolic abnormalities and irregular menstrual cycle with the purpose to improve fertility, whereas a lifestyle change with weight loss and physical activity is the first step in overweight and obese PCOS patients . Moreover, the association inositols-glucomannan may represent a good therapeutic strategy in the treatment of PCOS women with insulin resistance. Metabolomic approach is used to better define the pathophysiology of PCOS and to describe how different therapies can modify metabolic profiles. Although the association inositols-glucomannan may represent a good therapeutic strategy in the treatment of PCOS women with insulin resistance, the effect of inositols on the metabolomic profile of these women has not been described yet.
STUDY GOALDS AND OBJECTIVES The aim of this study is to analyze the metabolic profiles in women with PCOS before and after 3 months of therapy with a combination of myo-inositol, D-chiro-inositol and glucomannan, and compare these data with a group of healthy control women.
STUDY DESIGN The study is a prospective and observation. The inclusion criteria are: age between 18 and 35 years, overweight/obesity (BMI > 25 kg/m2), absence of any other acute intercurrent or chronic illness, a positive diagnosis of PCOS according to Rotterdam criteria. Exclusion criterion is using hormonal medications or drugs that affect insulin sensitivity (e.g., inositols or metformin) before enrollment. The use of myo-inositol (1.75 g), D-chiro-inositol (0.25 g) and glucomannan (4.0 g)/die must precede the recruitment of no more than 30 days. The decision to start treatment must have already been made before and independently of the start of the study. The use of inositol and glucomannan must take place according to the technical data sheet. In particular, myo-inositol (1.75 g), D-chiro-inositol (0.25 g) and glucomannan (4.0 g) are expected to be subdivided into two doses before main meals.
METHODOLOGY 4.1 Admission visit (V0) Once the eligibility criteria have been checked, the investigator will inform the patient about the objectives of the study during the initial visit (V0) and obtain written informed consent form. The compilation of a clinical card includes general information, anamnesis, BMI, the characteristics of the menstrual cycle, the amount of menstrual loss, the degree of hirsutism according to the Ferriman-Gallwey index and the degree of acne in agreement to the Global evaluation scale proposed in 2002 by FDA. The investigator will collect from the clinical documentation available the baseline glycaemia, insulin, triglycerides, cholesterol values before the start of the treatment. Furthermore, information on the ultrasound picture will be collected in terms of ovary volumes and antral follicles. A sample of 2-3 ml of basal blood will be collected for metabolomic evaluations, using a BD vacutainer (Becton Dickinson, Oxfordshire, UK) blood collection red tube (with no additives). After centrifugation, the sample will immediately freeze to -80 °C until the time of analysis. The patient will then be invited to continue treatment with myo-inositol (1.75 g), D-chiro-inositol (0.25 g) and glucomannan (4 g) die and to show up for control after 90 days (V1). 4.2 Follow-up visit 90th day (±15) after enrollment (V1) During the V1 the patient will be interviewed on the regular therapy and clinical symptoms, any adverse events and the course of the menstrual cycle. Furthermore, all patients will be re-evaluated regarding the anthropometric, biochemical and ultrasound parameters. At V1 a second blood sample of 2-3 ml will be collected with the same methods describe above. 4.3 Biochemical and metabolomics samples analysis Blood concentration of glucose, insulin, triglycerides and cholesterol is evaluated for control subjects and for cases at baseline and after 3 months of treatment. HOMA-IR si also calculated. Ovary volumes and the antral follicles count were evaluated by a vaginal ultrasound performed by a trained gynecologist. Metabolome extraction, purification and derivatization is carried out with the MetaboPrep GC kit (Theoreo srl, Montecorvino Pugliano [SA], Italy) according to the manufacturer's instructions. Details regarding metabolite extraction and the overall analytical scheme, including QA/QC sample analyses, were reported in Troisi et al. (2017, 2018)
Follow-Up Three months.
Data Management and Statistical Analysis At the end of the treatments the data collection of all patients is scheduled and the introduction of the same, in coded or clear form, in a database (Excel for windows) appropriately structured to contain all the expected items. In order to comply with the privacy law, the sensitive nominal data will be appropriately replaced by the numerical codes assigned to each patient, so that from the simple consultation of the data it will not be possible to deduce any individual direct reference. Moreover, the only data that can be extracted from the database are related to aggregated sets to be published for scientific purposes. Data is reported as mean±standard deviation for continuous variables and number (percentage) for categorical variables. Statistical analysis are performed using Statistica software (StatSoft, Oklahoma, USA) and Minitab (Minitab Inc, Pennsylvania, USA). Normal distribution of data is verified using the Shapiro-Wilks test. Since the data are normally distributed, the investigators use one-way ANOVA with the Tukey post hoc test for inter-group comparisons. The alpha (ɑ) value is set to 0.05. Pearson's chi-squared test is used to determine differences among groups for the categorical variables. For multivariate data analysis, the chromatographic data are tabulated with one sample per row and one variable (metabolite) per column. Data pre-treatment consists of normalizing each metabolite peak area to that of the internal standard followed by generalized log transformation and data scaling by autoscaling (mean-centered and divide it by standard deviation of each variable). PLS-DA is performed using the statistical software package R (Foundation for Statistical Computing, Vienna, Austria). Class separation is achieved by PLS-DA, which is a supervised method that uses multivariate regression techniques to extract, via linear combinations of original variables (X), the information that can predict class membership (Y). PLS regression is performed using the plsr function included in the R pls package. Classification and cross-validation is performed using the corresponding wrapper function included in the caret package. A permutation test is performed to assess the significance of class discrimination. In each permutation, a PLS-DA model is built between the data (X) and the permuted class labels (Y) using the optimal number of components determined by cross validation for the model based on the original class assignment. Variable Importance in Projection (VIP) scores are calculated for each metabolite. The VIP score is a weighted sum of squares of the PLS loadings, taking into account the amount of explained Y-variation in each dimension. The highest scoring VIP metabolites are compared in terms of fold changes (FC). FC is the ratio of the mean abundances between any two classes and is a measure describing how much a quantity changes going from an initial to a final value. The metabolic pathways are constructed using MetScape application of the software Cytoscape.
Expected Outcomes of the Study The goal of this pilot study is to identify a complex network of serum molecules that appear to be correlated with PCOS, and with a combined treatment with inositols and glucomannan.
Duration of the Project 24 months

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Controls	–	Other: Serum Metabolomics profilingHealthy subjects
Case	–	Other: Serum Metabolomics profilingPCOS affected subjects

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Young women with a PCOS diagnosis without intercurrent chronic illness and a matched healthy population.

Key inclusion criteria (3 listed)

overweight/obesity (BMI > 25 kg/m2);
absence of any other acute intercurrent or chronic illness;
a positive diagnosis of PCOS according to Rotterdam criteria.

Key exclusion criteria (1 listed)

Use of hormonal medications or drugs that affect insulin sensitivity (e.g., inositols or metformin) before enrollment

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
Serum Metabolomics profilingUntargeted serum metabolomics profiling	Other	Case, Controls

Primary outcome

Untargeted serum metabolomics profiling
Time frame: 6 months
Identify a complex network of serum molecules that appear to be correlated with PCOS, and with a combined treatment with inositols and glucomannan.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Background: PubMed 18950759Azziz R, Carmina E, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Futterweit W, Janssen OE, Legro RS, Norman RJ, Taylor AE, Witchel SF; Task Force on the Phenotype of the Polycystic Ovary Syndrome of The Androgen Excess and PCOS Society. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009 Feb;91(2):456-88. doi: 10.1016/j.fertnstert.2008.06.035. Epub 2008 Oct 23.
Background: PubMed 15181052Azziz R, Woods KS, Reyna R, Key TJ, Knochenhauer ES, Yildiz BO. The prevalence and features of the polycystic ovary syndrome in an unselected population. J Clin Endocrinol Metab. 2004 Jun;89(6):2745-9. doi: 10.1210/jc.2003-032046.
Background: PubMed 22153789Fauser BC, Tarlatzis BC, Rebar RW, Legro RS, Balen AH, Lobo R, Carmina E, Chang J, Yildiz BO, Laven JS, Boivin J, Petraglia F, Wijeyeratne CN, Norman RJ, Dunaif A, Franks S, Wild RA, Dumesic D, Barnhart K. Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group. Fertil Steril. 2012 Jan;97(1):28-38.e25. doi: 10.1016/j.fertnstert.2011.09.024. Epub 2011 Dec 6.
Background: PubMed 14711538Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.
Background: PubMed 28642705Sortino MA, Salomone S, Carruba MO, Drago F. Polycystic Ovary Syndrome: Insights into the Therapeutic Approach with Inositols. Front Pharmacol. 2017 Jun 8;8:341. doi: 10.3389/fphar.2017.00341. eCollection 2017.
Background: PubMed 29235868Troisi J, Sarno L, Landolfi A, Scala G, Martinelli P, Venturella R, Di Cello A, Zullo F, Guida M. Metabolomic Signature of Endometrial Cancer. J Proteome Res. 2018 Feb 2;17(2):804-812. doi: 10.1021/acs.jproteome.7b00503. Epub 2018 Jan 2.
Derived from this study: PubMed 30904021Troisi J, Cinque C, Giugliano L, Symes S, Richards S, Adair D, Cavallo P, Sarno L, Scala G, Caiazza M, Guida M. Metabolomic change due to combined treatment with myo-inositol, D-chiro-inositol and glucomannan in polycystic ovarian syndrome patients: a pilot study. J Ovarian Res. 2019 Mar 23;12(1):25. doi: 10.1186/s13048-019-0500-x.
Individual participant dataSharing planned: No

Related trials for PCOS

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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
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RecruitingPhase 1
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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.

Jacopo Troisi, CEO principal investigator

Theoreo Srl

Questions about this trial

What is this clinical trial studying?

An observational study of PCOS, run by University of Salerno.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Untargeted serum metabolomics profiling (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 NCT03608813, which also lists 7 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 3 Aug 2018.