Impact of Myo-Inositol vs Combined Myo-Inositol and Metformin Therapy on Conception Rates, Treatment Adherence, and Tolerability in Overweight Women Diagnosed With PCOS: A Randomized Controlled Study
Phase: PHASE3
Conditions: PCOS (Polycystic Ovary Syndrome)
Sponsor: PAEC general hospital

Official Title: 
 
Impact of Myo-Inositol vs Combined 
Myo-Inositol and Metformin Therapy 
on Conception Rates, Treatment 
Adherence, and Tolerability in 
Overweight Women Diagnosed With 
PCOS: A Randomized Controlled Study 
 
NCT Number: NCT ID not yet assigned 
Document Date: 23rd December 2025 
 
 
 

Background 
Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting 18–25% 
of reproductive age women in Pakistan. Characterized by hyperandrogenism, 
anovulation, and polycystic ovarian morphology, it is frequently associated with insulin 
resistance and obesity, particularly in South Asian populations. Compared to Western 
women, Pakistani women with PCOS often present with higher BMI, earlier onset of 
symptoms, and more severe metabolic profiles. While pharmacological treatments like 
metformin and myo-inositol are widely used, there is a lack of locally relevant data 
comparing their effectiveness, tolerability, and patient adherence, especially in 
overweight women seeking fertility treatment. 
Objective 
To compare the effects of myo-inositol alone versus myo-inositol combined with 
metformin on conception rates, side effect profiles, and treatment adherence among 
overweight women with PCOS in a Pakistani clinical setting. 
Methodology 
Study Design: Randomized, open-label, controlled clinical trial 
Study Setting: Gynecology OPD and IPD at PAEC general hospital, Islamabad. 
Study Population: 120 overweight women (BMI ≥ 25), aged 20–35, diagnosed with 
PCOS based on Rotterdam Criteria 
Intervention Groups: 
 Group A: Myo-inositol 4g/day 
 Group B: Myo-inositol 4g/day + Metformin 1500mg/day 
Duration: 6 months or until confirmed conception 
Primary Outcomes: Conception rate, side effect profile, and treatment adherence 
Secondary Outcomes: Menstrual regularity and ovulation status 
Data Collection: Patient diaries, ultrasound, hormone testing, questionnaires, and pill 
count 
Statistical Tools: SPSS; significance set at p < 0.05 

Eligibility Criteria 
Inclusion Criteria: 
 Women aged 20 to 35 years 
 BMI ≥25 kg/m² 
 Fulfilled at least two of the three Rotterdam criteria 
 Attempting to conceive naturally 
 No use of hormonal drugs or insulin-sensitizers in the past three months 
Exclusion Criteria: 
 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 
Ethical Considerations 
The study received ethical approval from the Institutional Review Board. Written 
informed consent was obtained from all participants. Confidentiality, voluntary 
participation, and the right to withdraw at any stage were ensured. 
Discussion 
This study addresses a critical gap in PCOS management research in Pakistan by 
focusing on the comparative evaluation of two commonly used insulin sensitizers in a 
population with unique metabolic characteristics. The investigation explores the clinical 
and practical implications of both therapies in improving fertility while also considering 
tolerability and adherence—key factors in long-term success, especially in under-
resourced healthcare settings. Cultural, socioeconomic, and behavioral factors affecting 
Pakistani women’s access and response to fertility care further underscore the need for 
context-specific treatment strategies. 
Conclusion 
There is a need for well-tolerated, effective, and accessible fertility treatments for 
overweight women with PCOS in Pakistan. This study contributes evidence to guide 
clinicians in selecting patient-centered treatment options, potentially positioning myo-
inositol as a preferred first-line agent due to its favorable safety and adherence profile. 

Clinical Implications 
In the Pakistani healthcare setting, clinicians may consider initiating treatment with myo-
inositol alone for overweight PCOS patients seeking conception, with metformin 
reserved for cases demonstrating poor metabolic response or persistent ovulatory 
dysfunction. 
Strengths and Limitations 
Key strengths include the randomized design and population-specific focus, adding to the 
limited local data on PCOS. Limitations include the short follow-up duration and reliance 
on self-reported adherence. Future studies with extended observation periods and 
objective adherence metrics are recommended. 
PCOS Clinical Trial – Data Collection Form 
SECTION 1: PARTICIPANT IDENTIFICATION 
Patient Name: ____________ 
Date of Enrollment: ___ / ___ / 2025 
Assigned Group: 
 Group A – Myo-inositol only 
 Group B – Myo-inositol + Metformin 
SECTION 2: DEMOGRAPHICS 
Age (years): ______ 
Weight (kg): ______ 
Height (cm): ______ 
BMI: ______ (calculated) 
Marital Status: ☐ Married ☐ Single 
Duration of Infertility: ______ years 
SECTION 3: CLINICAL HISTORY 
 Irregular menstruation: ☐ Yes ☐ No  Cycle length: _____ days 
 Hirsutism: ☐ Yes ☐ No  Score: _____ (Ferriman-Gallwey) 
 Acne: ☐ Yes ☐ No  Severity: ☐ Mild ☐ Moderate ☐ Severe 

 Previous PCOS Treatment: ☐ Yes ☐ No  Type: _______________ 
SECTION 4: FOLLOW-UP AND TREATMENT MONITORING 
Visit | Side Effects | Compliance (%) | Menstrual Regularity | Ovulation Confirmed | 
Pregnancy Confirmed 
Month 1 ___________________________ _______% ☐ Yes ☐ No ☐ Yes ☐ No ☐ Yes 
☐ No 
Month 2 ___________________________ _______% ☐ Yes ☐ No ☐ Yes ☐ No ☐ Yes 
☐ No 
Month 3 ___________________________ _______% ☐ Yes ☐ No ☐ Yes ☐ No ☐ Yes 
☐ No 
Month 6 / Final ____________________ _______% ☐ Yes ☐ No ☐ Yes ☐ No ☐ Yes ☐ 
No 
SECTION 5: ULTRASOUND & LABORATORY MONITORING 
 Confirmed Ovulation Method: ☐ Mid-luteal Progesterone ☐ Ultrasound 
 Ultrasound Findings: ___________________________ 
 Hormonal Tests: FSH: ____ LH: ____ AMH: ____ 
 Fasting Glucose: ____ mg/dL, Insulin: ____ µU/mL 
Participant Information & Consent Form 
Study Title: Comparison of Myo-inositol Alone versus Myo-inositol plus Metformin in 
Overweight Women with PCOS 
Principal Investigator: Dr. Maria Amin, Department of Obstetrics and Gynecology, 
PAEC General Hospital, Islamabad 
Why is this study being done? 
We want to learn whether myo-inositol alone works as well as myo-inositol plus 
metformin in helping overweight women with PCOS to conceive. We will also look at 
side effects, treatment use, and menstrual health. 
What will I be asked to do? 
 Be randomly placed into one of two groups: 
 Group A: Myo-inositol (4 g/day) 
 Group B: Myo-inositol (4 g/day) + Metformin (1500 mg/day) 

 Take the assigned treatment for six months 
 Attend follow-up visits and ultrasound checks 
 Report any side effects and your treatment use 
Benefits 
 You may have improved menstrual cycles, ovulation, and a chance of pregnancy. 
 Your participation will help improve treatment options for women with PCOS. 
Risks 
 Myo-inositol: Usually safe with few side effects. 
 Metformin: May cause stomach upset, nausea, or diarrhea. 
 No serious risks are expected. 
Voluntary Participation 
Taking part is your choice. You may stop at any time without affecting your medical 
care. 
Confidentiality 
Your information will be kept private. Results will not identify you. 
Contact 
If you have questions, please contact: Dr. Maria Amin – mariaamin13@yahoo.com 
Consent 
I have read and understood this information. I agree to take part in this study. 
Participant’s Name: ___________________________ 
Signature/Thumbprint: _________________________ 
Date: ___________________ 
Investigator’s Signature: ______________________ 
Date: ___________________