NCT07323589

Brief Summary

The goal of this clinical trial (prospective randomized controlled trial) is to compare whether myo-inositol alone or in combination with metformin can improve conception rates, treatment compliance, and side-effect profiles in overweight women (BMI ≥25 kg/m²) diagnosed with polycystic ovary syndrome (PCOS). The main questions it aims to answer are:

  • Be randomly assigned to receive either myo-inositol alone or myo-inositol plus metformin for six months.
  • Attend follow-up visits for monitoring of pregnancy outcomes confirmed by ultrasound.
  • Report any side effects experienced during treatment.
  • Provide information on treatment adherence and dropout rates.
  • Be assessed for menstrual regularity and ovulation rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_3

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

January 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

November 14, 2025

Last Update Submit

December 22, 2025

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

Myo-inositolPolycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Confirmed Clinical Pregnancy by Ultrasound

    Clinical pregnancy defined as the presence of a gestational sac confirmed by ultrasound.

    Up to 6 months or until pregnancy is confirmed

Study Arms (2)

arm 1

EXPERIMENTAL

in the comparison group of study: Researchers will compare Group A (myo-inositol 4 g/day)

Drug: Myoinositol

arm 2

EXPERIMENTAL

group B will be a combination group (Metformin 1500mg per day and Myo inositol 4gram per day)

Drug: MyoinositolDrug: Metformin 1500 mg daily

Interventions

Metformin 1500 mg dailyDRUG

metfromin plus myoinositol 1500mg and 4gram per day respectively

arm 2
MyoinositolDRUG

myo-inositol (4 g/day)

arm 1arm 2

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales of reproductive age group
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 20 to 35 years
  • BMI ≥25 kg/m²
  • Fulfilled at least two of the three Rotterdam criteria for PCOS
  • Attempting to conceive naturally
  • No use of hormonal drugs or insulin-sensitizers in the past three months

You may not qualify if:

  • Endocrine disorders (e.g., diabetes, thyroid dysfunction)
  • Hepatic impairment
  • Kidney disease
  • Gastrointestinal or malabsorption issues (IBS, IBD, celiac disease)
  • Known allergies to metformin or inositol
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAEC general hospital

Islamabad, Isb, 440000, Pakistan

Location

Related Publications (2)

  • Agrawal A, Mahey R, Kachhawa G, Khadgawat R, Vanamail P, Kriplani A. Comparison of metformin plus myoinositol vs metformin alone in PCOS women undergoing ovulation induction cycles: randomized controlled trial. Gynecol Endocrinol. 2019 Jun;35(6):511-514. doi: 10.1080/09513590.2018.1549656. Epub 2019 Jan 7.

    PMID: 30614289RESULT

  • Thakur SS, Anjum S, Siddiqui SS. Randomised controlled trial: comparing effects of metformin versus myoinositol versus metformin and myoinositol on ovarian functions and metabolic factors in polycystic ovarian syndrome. Int J Reprod Contracept Obstet Gynecol. 2020;9(6):2542 50. doi:10.18203/2320-1770.ijrcog20202030

    RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

InositolMetformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesBiguanidesGuanidinesAmidines

Study Officials

  • Maria Amin

    PAEC general hospital, H-11/4, islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Resident Gynecology and Obstetrics

Study Record Dates

First Submitted

November 14, 2025

First Posted

January 7, 2026

Study Start

January 1, 2025

Primary Completion

July 30, 2025

Study Completion

October 25, 2025

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)