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

October 2, 2025 updated by: Sadia Fatima, Aga Khan University

Association of Serum Biomarkers in Polycystic Ovarian Syndrome (PCOS) Females With and Without Metformin Versus Healthy Controls

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • DBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

a) Patients Falling into PCOS as per Rotterdam criteria

Exclusion Criteria:

  1. Systemic diseases like atherosclerosis,
  2. Diabetes mellitus
  3. Hypertension
  4. congenital adrenal hyperplasia, androgen secreting tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin Treated PCO
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
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)
No Intervention: PCO without Metformin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hormonal profile and menstural Cycle after Metformin use
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in symptoms associated with PCO after intervention
Time Frame: 8 weeks
Subjects will be asked to score on a Likert scare (0-5) change in the mood swings, menstural cycle frequency, facial hair quantity and quality, and dietary and bowel movement improvement.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

University of Karachi

Investigators

  • Study Director: Sadia Fatima, PhD, Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

October 2, 2025

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08232/SC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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