PCOS (Polycystic Ovary Syndrome)PCOS HOMA IRNCT07453680
Comparative Effect of Myo-inositol With That of D-chiro-inositol on Insulin Resistance in Infertile Women With Polycystic Ovary Syndrome (PCOS).
A study testing Tab Myo-inositol 750mg and D-chiro-inositol 500mg in people with PCOS (Polycystic Ovary Syndrome), run by Mst.Sumyara Khatun at 1 site in Bangladesh.
Trial summary
This randomized controlled trial was conducted in the Department of Reproductive Endocrinology and Infertility, BSMMU.A total of 80 infertile women ofPCOS withinsulinresistanceparticipatedinthestudyandwere randomly allocated into 2 groups. One group was treated with tab. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Tab Myo-inositol 750mg and D-chiro-inositol 500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2023to 1 May 2024
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed case of PCOS according to Rotterdam criteria
- Primary or secondary infertility
- Insulin resistance (HOMA-IR >2)
Who cannot join
- Age less than 18 years and more than 35 years
- BMI less than 18.5kg/ m² and more than 30 kg/ m²
- Endocrine disorders (Diabetes mellitus, hypothyroidism, hyperprolactinemia)
- Any contraindications to MI or DCI
- Any insulin sensitizer (metformin or inositol) in the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Myo-inositol Compared to D-chiro-inositol on Insulin Resistance in Infertile Women With Polycystic Ovary Syndrome: A Non-inferiority Trial
This randomized controlled trial was conducted in the Department of Reproductive Endocrinology and Infertility, BSMMU.A total of 80 infertile women ofPCOS withinsulinresistanceparticipatedinthestudyandwere randomly allocated into 2 groups. One group was treated with tab. Myoinositol (MI) 750 mg thrice daily and other group with D-chiro-inositol (DCI) 500 mg once daily for 3 months. After 3 months, follow up fasting blood sugar, fasting insulin and HOMA-IR were measured
Read the detailed description
After obtaining approval of the Institutional Review Board (IRB), this randomized clinical trial was conducted at Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka. Already diagnosed patients of polycystic ovary syndrome with infertilitywithHOMA-IR>2.0attendingintheOPDofReproductiveEndocrinology and Infertility Department at BSMMU were the study population. After approval of protocol, women with PCOS fulfilling inclusion and exclusion criteria were explained in detail regarding the objectives, rationality, procedure, and potential benefits of the study. The patients were counseled regarding the drugs and unexpected side-effects and an informed written consent was taken.
Those who gave voluntary informed consent were randomized to any of the two treatment arms.Afterenrollmentofthepatients, allocation was doneby computerized permuted block randomization. Allocation concealment was done using serially numbered closed opaque envelopes. Each envelope was labeled with a serial number and had a card inside notingthe intervention drug. Allocation never changed after opening the closed envelope. Eligible women were randomly allocated into two groups:
Experimental group: Myoinositol group:Tab Myoinositol (Tab Myosit, Renata Pharmaceutical Limited)750mg was given three times daily for 3 months
Controlgroup:D-chiro-inositol group: Cap D-chiro-inositol (Cap Chirocyst,Radiant Pharmaceutical Limited) 500 mg was given once daily for 3 months.
Data were collected through interviews, physical examinations and laboratory investigations. Prior to commencement of treatment, full assessment including demographic and clinical information (age, weight, height, BMI, waist circumference, hirsutism, acne, acanthosis nigricans)and the result of baseline investigations were undertaken. All the data were enrolled in the clinical record form for this study.
Follow up:
During the study period, patients were contacted every monthover telephone and inquired about the compliance to the regimen as well as any side effects.Second visit was scheduled at the end of 3rd month to assess the treatment outcome.
End points:
After the allotted study period of 3 months, fasting blood samples were collected to estimate fasting blood sugar level and fasting insulin. HOMA-IR was calculated using specific formula and comparison was made between the effect of myo-inositol and D-chiro-inositolon insulin resistance parameters in infertile women with polycystic ovary syndrome.
For each and every subject, a separate clinical record form was prepared. Data were collected from the patients on different visits on variables of interest using interview, observation, clinical examination, investigations and from the history sheet of the patients. The cumulative data were then subjected to analysis.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Tab Myo-inositol 750mg, D-chiro-inositol 500mg
- Keywords
- PCOS, Myo-inositol, D-chiro-inositol, Insulin resistance
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tab Myo-inositol 750mgDietary supplement
Tab Myo-inositol 750mg 3 times daily for 3 months
D-chiro-inositol 500mgDietary supplement
Cap D-chiro-inositol 500 mg once daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: Myoinositol Group | Experimental | Myo-inositol group:Tab Myo-inositol 750mg 3 times daily for 3 months Receives: Dietary Supplement: Tab Myo-inositol 750mg |
| Comparator arm: D chiro-inositol group | Active comparator | D-chiro-inositol group: Cap D-chiro-inositol 500 mg once daily for 3 months Receives: Dietary Supplement: D-chiro-inositol 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Fasting insulin
Serum fasting insulinlevel wasdeterminedby chemiluminescent microparticle immunoassay (CMIA) usingcommertially available Alinityi reagent kit
Measured: 12 weeks
HOMA-IR
HOMA-IR was calculated by usingfollowing formula:
HOMA-IR= Fasting glucose (mmol/L) x Fasting insulin (µU/ml) divided by 22.5. HOMA-IR was 1.93 at the 75thpercentile among Indian population and 1.82 at the75th percentile among Pakistani population (Hydrie et al, 2012).
So, for the present study, HOMA-IR >2 was considered as insulin resistance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jun 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mst.Sumyara Khatun
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh Medical University
- Responsible party
- Sponsor-investigator, Mst.Sumyara Khatun, Bangladesh Medical University
- Investigators
- Shakeela Ishrat, FCPS, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453680
- Sponsor's protocol ID
- 4350
- Acronym
- PCOS HOMA IR
- Status last verified
- May 2024
- First submitted
- 10 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Genazzani AD, Santagni S, Rattighieri E, Chierchia E, Despini G, Marini G, Prati A, Simoncini T. Modulatory role of D-chiro-inositol (DCI) on LH and insulin secretion in obese PCOS patients. Gynecol Endocrinol. 2014 Jun;30(6):438-43. doi: 10.3109/09513590.2014.897321. Epub 2014 Mar 7.
PubMed 24601829Merviel P, Bouee S, Menard M, Le Martelot MT, Roche S, Lelievre C, Chabaud JJ, Jacq C, Drapier H, Beauvillard D. [Which ovarian stimulation to which women: The polycystic ovary syndrome (PCOS)]. Gynecol Obstet Fertil Senol. 2017 Nov;45(11):623-631. doi: 10.1016/j.gofs.2017.10.001. French.
PubMed 29100822
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myo-inositol Compared to D-chiro-inositol on Insulin Resistance in Infertile Women With Polycystic Ovary Syndrome: A Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07453680
- Acronym / sponsor ID
- PCOS HOMA IR / 4350
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- PCOS, Myo-inositol, D-chiro-inositol, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mst.Sumyara KhatunUniversity, hospital or other
- Collaborators
- Bangladesh Medical University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 6 Mar 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 randomized controlled trial was conducted in the Department of Reproductive Endocrinology and Infertility, BSMMU.A total of 80 infertile women ofPCOS withinsulinresistanceparticipatedinthestudyandwere randomly allocated into 2 groups. One group was treated with tab. Myoinositol (MI) 750 mg thrice daily and other group with D-chiro-inositol (DCI) 500 mg once daily for 3 months. After 3 months, follow up fasting blood sugar, fasting insulin and HOMA-IR were measured
Detailed description
After obtaining approval of the Institutional Review Board (IRB), this randomized clinical trial was conducted at Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka. Already diagnosed patients of polycystic ovary syndrome with infertilitywithHOMA-IR>2.0attendingintheOPDofReproductiveEndocrinology and Infertility Department at BSMMU were the study population. After approval of protocol, women with PCOS fulfilling inclusion and exclusion criteria were explained in detail regarding the objectives, rationality, procedure, and potential benefits of the study. The patients were counseled regarding the drugs and unexpected side-effects and an informed written consent was taken.
Those who gave voluntary informed consent were randomized to any of the two treatment arms.Afterenrollmentofthepatients, allocation was doneby computerized permuted block randomization. Allocation concealment was done using serially numbered closed opaque envelopes. Each envelope was labeled with a serial number and had a card inside notingthe intervention drug. Allocation never changed after opening the closed envelope. Eligible women were randomly allocated into two groups:
Experimental group: Myoinositol group:Tab Myoinositol (Tab Myosit, Renata Pharmaceutical Limited)750mg was given three times daily for 3 months
Controlgroup:D-chiro-inositol group: Cap D-chiro-inositol (Cap Chirocyst,Radiant Pharmaceutical Limited) 500 mg was given once daily for 3 months.
Data were collected through interviews, physical examinations and laboratory investigations. Prior to commencement of treatment, full assessment including demographic and clinical information (age, weight, height, BMI, waist circumference, hirsutism, acne, acanthosis nigricans)and the result of baseline investigations were undertaken. All the data were enrolled in the clinical record form for this study.
Follow up:
During the study period, patients were contacted every monthover telephone and inquired about the compliance to the regimen as well as any side effects.Second visit was scheduled at the end of 3rd month to assess the treatment outcome.
End points:
After the allotted study period of 3 months, fasting blood samples were collected to estimate fasting blood sugar level and fasting insulin. HOMA-IR was calculated using specific formula and comparison was made between the effect of myo-inositol and D-chiro-inositolon insulin resistance parameters in infertile women with polycystic ovary syndrome.
For each and every subject, a separate clinical record form was prepared. Data were collected from the patients on different visits on variables of interest using interview, observation, clinical examination, investigations and from the history sheet of the patients. The cumulative data were then subjected to analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: Myoinositol Group | Experimental | Dietary Supplement: Tab Myo-inositol 750mgMyo-inositol group:Tab Myo-inositol 750mg 3 times daily for 3 months |
| Comparator arm: D chiro-inositol group | Active comparator | Dietary Supplement: D-chiro-inositol 500mgD-chiro-inositol group: Cap D-chiro-inositol 500 mg once daily for 3 months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed case of PCOS according to Rotterdam criteria
- Primary or secondary infertility
- Insulin resistance (HOMA-IR >2)
Key exclusion criteria (5 listed)
- Age less than 18 years and more than 35 years
- BMI less than 18.5kg/ m² and more than 30 kg/ m²
- Endocrine disorders (Diabetes mellitus, hypothyroidism, hyperprolactinemia)
- Any contraindications to MI or DCI
- Any insulin sensitizer (metformin or inositol) in the last three months
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 |
|---|---|---|
| Tab Myo-inositol 750mgTab Myo-inositol 750mg 3 times daily for 3 months | Dietary supplement | Experimental arm: Myoinositol Group |
| D-chiro-inositol 500mgCap D-chiro-inositol 500 mg once daily for 3 months | Dietary supplement | Comparator arm: D chiro-inositol group |
Primary outcome
• Fasting insulin
Time frame: 12 weeks
Serum fasting insulinlevel wasdeterminedby chemiluminescent microparticle immunoassay (CMIA) usingcommertially available Alinityi reagent kit
HOMA-IR
Time frame: 12 weeks
HOMA-IR was calculated by usingfollowing formula: HOMA-IR= Fasting glucose (mmol/L) x Fasting insulin (µU/ml) divided by 22.5. HOMA-IR was 1.93 at the 75thpercentile among Indian population and 1.82 at the75th percentile among Pakistani population (Hydrie et al, 2012). So, for the present study, HOMA-IR >2 was considered as insulin resistance
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 6 Mar 2026.
- Results publication: PubMed 24601829Genazzani AD, Santagni S, Rattighieri E, Chierchia E, Despini G, Marini G, Prati A, Simoncini T. Modulatory role of D-chiro-inositol (DCI) on LH and insulin secretion in obese PCOS patients. Gynecol Endocrinol. 2014 Jun;30(6):438-43. doi: 10.3109/09513590.2014.897321. Epub 2014 Mar 7.
- Results publication: PubMed 29100822Merviel P, Bouee S, Menard M, Le Martelot MT, Roche S, Lelievre C, Chabaud JJ, Jacq C, Drapier H, Beauvillard D. [Which ovarian stimulation to which women: The polycystic ovary syndrome (PCOS)]. Gynecol Obstet Fertil Senol. 2017 Nov;45(11):623-631. doi: 10.1016/j.gofs.2017.10.001. French.
- Individual participant dataSharing planned: No
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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.
Shakeela Ishrat, FCPS study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tab Myo-inositol 750mg and D-chiro-inositol 500mg in people with PCOS (Polycystic Ovary Syndrome), run by Mst.Sumyara Khatun at 1 site in Bangladesh.
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 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: finished, as of the sponsor's last update on 6 Mar 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 Bangladesh. 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.
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?
• Fasting insulin (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT07453680, which also lists 2 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 6 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.