Clinical trial · Interventional
Relationship Between Metformin Treatment, Anemia, and Erythropoietin Levels in Women With Polycystic Ovary Syndrome in Jordan
Effects of Routine Metformin Therapy on Insulin Resistance, Iron Metabolism, Erythropoietin, Lipid Profile, and Hematological Parameters in Jordanian Women With Polycystic Ovary Syndrome: A Prospective Longitudinal Interventional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance Syndrome | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome (PCOS) Women | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Routine Metformin Therapy
- description
- Adult women diagnosed with polycystic ovary syndrome (PCOS) received routine metformin therapy (500 mg orally twice daily) for six months as part of standard clinical care. Clinical and laboratory assessments were performed at baseline, three months, and six months to evaluate changes in insulin resistance, iron metabolism, erythropoietin concentrations, lipid profile, and hematological parameters.
- interventionNames
- Drug: Metformin
Primary outcomes (2)
- measure
- Change in insulin resistance (HOMA-IR)
- timeFrame
- Baseline and 6 months
- description
- To evaluate the change in insulin resistance using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) following six months of routine metformin therapy in women with polycystic ovary syndrome.
- measure
- Change in serum ferritin concentration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDRotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004. PMID 14711538
- RESULTJohnson NP. Metformin use in women with polycystic ovary syndrome. Ann Transl Med. 2014 Jun;2(6):56. doi: 10.3978/j.issn.2305-5839.2014.04.15. PMID 25333031
- RESULTTeede HJ, Tay CT, Laven J, Dokras A, Moran LJ, Piltonen TT, Costello MF, Boivin J, M Redman L, A Boyle J, Norman RJ, Mousa A, Joham AE; International PCOS Network. Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. Fertil Steril. 2023 Oct;120(4):767-793. doi: 10.1016/j.fertnstert.2023.07.025. Epub 2023 Aug 14. PMID 37589624