Relationship Between Metformin Treatment, Anemia, and Erythropoietin Levels in Women With Polycystic Ovary Syndrome in Jordan

NCT07759674 | Completed Phase 4

• 1 other identifier: Metformin --2026
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome (PCOS) Women; Insulin Resistance Syndrome

Keywords

Polycystic Ovary Syndrome; Metformin; Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• Change in insulin resistance (HOMA-IR)

  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.

  Baseline and 6 months

• Change in serum ferritin concentration

  To evaluate the change in serum ferritin concentration after six months of routine metformin therapy.

  Baseline and 6 months

Secondary Outcomes (5)

• Change in fasting blood glucose

  Baseline and 6 months

• Change in fasting serum insulin

  Baseline and 6 months

• Change in serum iron concentration

  Baseline and 6 months

• Change in hematological parameters

  Baseline and 6 months

• Change in body mass index (BMI)

  Baseline and 6 months

Study Arms (1)

Routine Metformin Therapy

EXPERIMENTAL

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.

Drug: Metformin

Interventions

Metformin DRUG

Metformin hydrochloride tablets, 500 mg administered orally twice daily for six months as part of routine clinical management of women with polycystic ovary syndrome (PCOS).

Routine Metformin Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jerash Private University: lead

Study Sites (1)

Ministry of Health Primary Healthcare Centers

Amman, 009627, Jordan

Location

Related Publications (3)

• Rotterdam 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 BACKGROUND

• Johnson 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 RESULT

• Teede 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 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.Dr

Model Details: This was a prospective single-group longitudinal interventional study. All enrolled participants with polycystic ovary syndrome (PCOS) received routine metformin therapy (500 mg twice daily) for six months. Clinical and laboratory assessments were performed at baseline, three months, and six months to evaluate changes in metabolic, iron-related, lipid, erythropoietin, and hematological parameters. No parallel control group was included.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start: June 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 12, 2026

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication.
• Access Criteria: De-identified individual participant data, the study protocol, and the statistical analysis plan will be available to qualified researchers upon reasonable request. Requests must include a scientifically sound research proposal. Access will be granted following review and approval by the corresponding author and the sponsoring institution, and after execution of a data sharing agreement to ensure participant confidentiality and appropriate use of the data.

Locations

JO (1)