Evaluation of Metformin Effect on the Fertility of Women Treated With 131I for Thyroid Cancer

• Status: Not yet recruiting
• Trial end date: 2026-04-30
• Target enrollment: 0
• Participant gender: Female

Summary

This study is aimed to investigate the metformin effect on the fertility of women treated with 131 I for thyroid cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Bialystok
• Collaborator: Medical Research Agency
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Female subjects in reproductive age >18 <45.

• Subjects with diagnosed papillary thyroid carcinoma with various pathological, stage TNM (I-II).

• Subjects not treated with 131I.

• Serum TSH concentration 0.1-4.9 mU/l.

• Willingness to comply with protocol procedures.

Exclusion Criteria:

• Hypersensitivity to metformin.

• Subjects with polycystic ovarian syndrome or other diseases of the ovaries (primary / secondary ovarian failure).

• Subjects taking metformin during last week.

• Subjects with liver malfunction and abnormal hepatitis marker results (ALT and AST activity >3ULN.

• Subjects with eGFR below 45ml/min/1.73m2.

• Subjects with lactic acidosis or having history of metabolic acidosis.

• Subjects with serum AMH concentration below lower range norm.

• Subjects with history of congestive heart disease NYHA stage III/IV.

• Subjects with acute myocardial ischemia (CCS 3-4).

• Subjects with history of sepsis or severe infection.

• Subject with lung disease (uncontrolled asthma based on GINA 2000 Guidelines and COPD GOLD ≥ 3 stage).

• Positive result of pregnancy test or pregnancy planned during the study.

• Alcohol or other substance dependent syndromes.

• BMI <18.5 kg/m2.

• Accompanying diseases with poor prognosis in the opinion of the researcher.

• As per Investigator (or his designee) judgement, subject cannot participate in the study due to reasons (i.e. medical, psychiatric and/or social reason).

• Unreliability or lack of cooperation.