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Completed
NCT07759674
Relationship Between Metformin Treatment, Anemia, and Erythropoietin Levels in Women With Polycystic Ovary Syndrome in Jordan
Conditions: Polycystic Ovary Syndrome (PCOS) Women, Insulin Resistance Syndrome
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 25
Sponsor: Jerash Private University
Location: Ministry of Health Primary Healthcare Centers Amman
Summary
This prospective longitudinal interventional study aims to evaluate the effects of routine metformin therapy on metabolic, iron-related, erythropoietin, lipid, and hematological parameters in adult women with polycystic ovary syndrome (PCOS). Participants diagnosed with PCOS according to established diagnostic criteria receive routine metformin therapy for six months as part of standard clinical care. Clinical and laboratory assessments are performed at baseline, three months, and six months to evaluate changes in insulin resistance, fasting blood glucose, fasting serum insulin, serum ferritin, serum iron, erythropoietin (EPO), lipid profile, and hematological indices. The study also examines the relationships between metabolic, iron-related, and hematological biomarkers during metformin treatment.
Eligibility Criteria
Inclusion Criteria:
* Women aged 18-45 years.
* Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam diagnostic criteria.
* Eligible for routine metformin therapy as determined by the treating gynecologist.
* Willing and able to provide written informed consent.
* Willing to attend scheduled follow-up visits and complete all study assessments over the six-month study period.
Exclusion Criteria:
* Pregnancy or breastfeeding.
* Diagnosis of type 1 diabetes mellitus or established type 2 diabetes requiring insulin therapy.
* History of chronic kidney disease, chronic liver disease, hematological disorders, malignancy, or other severe systemic diseases.
* Current use of medications known to affect glucose metabolism, iron metabolism, erythropoietin levels, or hematological parameters within the previous three months, other than routine metformin prescribed as part of the study.
* Known hypersensitivity or contraindication to metformin. Inability or unwillingness to complete the scheduled follow-up assessments.
* Participation in another interventional clinical trial during the study period.
Source: ClinicalTrials.gov (NCT07759674). StuddyBuddy aggregates publicly available trial information.