Serum Biomarker Levels Improvement in Poly Cystic Ovarian Syndrome: Impact of Metformin Compared to Healthy Controls

NCT06479434 | Completed

• 1 other identifier: 08232/SC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to assess the effect of drug metformin in improving the fertility hormones and reducing the inflammatory hormones in polycystic ovarian syndrome (PCOS) patients. We wish to answer the question whether metformin is necessary to improve PCOS symptoms versus simple lifestyle modification. Participants once diagnosed with PCOS will be given metformin to be sued for 8 weeks. They will be asked to provide blood samples on day 0 and after 8 weeks of metformin use. The blood sample will be used to measure the hormonal and inflammatory profile. In addition, they will be required to compete a questionnaire regarding symptoms such as decrease in facial hair growth, improvement in menstrual cycle etc.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change in hormonal profile and menstural Cycle after Metformin use

  Serum reproductory hormone levels (follicle stimulating hormone, testosterone), inflammatory hormones (tumor necrosis factor, c reactive protein) will be measured at day 0 and after 8 weeks of intervention

  8 weeks

Secondary Outcomes (1)

• Change in symptoms associated with PCO after intervention

  8 weeks

Study Arms (2)

Metformin Treated PCO

EXPERIMENTAL

After taking informed consent demographic data like name, age, anthropometric measurements (blood pressure, BMI, weight, height)will be recorded by researcher Body mass index (BMI), waist circumference, waist to hip ratio will be evaluated. Blood samples will be collected after an overnight fast of 8 to 10 hours. Then metformin will be given to subjects a dose of 500 mg three times a day for 8 weeks. Serum biomarkers and inflammatory markers will be assessed at day 0 and after 8 weeks post metformin administration.

Drug: Metformin

PCO without Metformin

NO INTERVENTION

After taking informed consent demographic data like name, age, anthropometric measurements (blood pressure, BMI, weight, height)will be recorded by researcher Body mass index (BMI), waist circumference, waist to hip ratio will be evaluated. Blood samples will be collected after an overnight fast of 8 to 10 hours. . Serum biomarkers and inflammatory markers will be assessed at day 0 only.

Interventions

Metformin DRUG

Females diagnosed with polycystic syndrome will be given metformin tablets for 8 weeks and followed up. Blood samples will be collected along with anthropometric data (weight (kg), height (m) etc)

Metformin Treated PCO

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a) Patients Falling into PCOS as per Rotterdam criteria

You may not qualify if:

• Systemic diseases like atherosclerosis,
• Diabetes mellitus
• Hypertension
• congenital adrenal hyperplasia, androgen secreting tumors

Sponsors & Collaborators

• Aga Khan University: lead
• University of Karachi: collaborator

Study Sites (1)

DBBS

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Sadia Fatima, PhD

  Aga Khan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: June 24, 2024
• Primary Completion: May 30, 2025
• Study Completion: October 2, 2025
• Last Updated: October 7, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)