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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06479434

Enrollment

110

Registered

2024-06-28

Start date

2024-06-24

Completion date

2025-10-02

Last updated

2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Polycystic Ovary Syndrome

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.

Interventions

DRUGMetformin

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in hormonal profile and menstural Cycle after Metformin use	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

Secondary

Measure	Time frame	Description
Change in symptoms associated with PCO after intervention	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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026