NCT07453680

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
Last Updated

March 6, 2026

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

February 10, 2026

Last Update Submit

March 3, 2026

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

PCOSMyo-inositolD-chiro-inositolInsulin resistance

Outcome Measures

Primary Outcomes (2)

  • • Fasting insulin

    Serum fasting insulinlevel wasdeterminedby chemiluminescent microparticle immunoassay (CMIA) usingcommertially available Alinityi reagent kit

    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

    12 weeks

Study Arms (2)

Experimental arm: Myoinositol Group

EXPERIMENTAL

Myo-inositol group:Tab Myo-inositol 750mg 3 times daily for 3 months

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

Dietary Supplement: D-chiro-inositol 500mg

Interventions

Tab Myo-inositol 750mgDIETARY_SUPPLEMENT

Tab Myo-inositol 750mg 3 times daily for 3 months

Experimental arm: Myoinositol Group
D-chiro-inositol 500mgDIETARY_SUPPLEMENT

Cap D-chiro-inositol 500 mg once daily for 3 months

Comparator arm: D chiro-inositol group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed case of PCOS according to Rotterdam criteria
  • Primary or secondary infertility
  • Insulin resistance (HOMA-IR \>2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (2)

  • 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.

    PMID: 24601829RESULT

  • Merviel 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.

    PMID: 29100822RESULT

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Interventions

Inositol

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Shakeela Ishrat, FCPS

    Bangladesh Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Officer

Study Record Dates

First Submitted

February 10, 2026

First Posted

March 6, 2026

Study Start

June 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

March 6, 2026

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)