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Completed

NCT Number: NCT06479434

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

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DBBS

Karachi, Sindh, 74800, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

a) Patients Falling into PCOS as per Rotterdam criteria

Exclusion criteria

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

Treatment and study plan

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • University of Karachi

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2024
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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