Metformin and fertility after 131I treatment for thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 3 trial investigates the potential effect of metformin on fertility outcomes in women aged 18 to 44 who have papillary thyroid cancer treated with 131I. Participants receive metformin alongside radioactive iodine therapy to explore whether Metformin influences reproductive parameters after thyroid cancer treatment. The study will monitor safety and fertility-related endpoints, including ovarian function markers and menstrual status, in addition to standard thyroid cancer management. Eligibility focuses on women with early-stage papillary carcinoma and without prior 131I treatment, with exclusions for metabolic, hepatic, renal, or cardiac conditions that could confound results. The trial is sponsored by the Medical University of Bialystok with collaboration from Polish research and cancer centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female subjects in reproductive age \>18 \<45 years.
2. Subjects with diagnosed papillary thyroid carcinoma with various pathological stage TNM (I-II).
3. Subjects not treated with 131I
4. Willingness to comply with protocol procedures.

Exclusion Criteria:

1. Hypersensitivity to metformin.
2. Subjects with polycystic ovarian syndrome or other diseases of the ovaries (primary / secondary ovarian failure).
3. Subjects taking metformin during last week.
4. Subjects with liver malfunction and abnormal hepatitis marker results (ALT and AST activity \>3ULN.\*
5. Subjects with eGFR below 45ml/min/1.73m2.\*
6. Subjects with lactic acidosis or having history of metabolic acidosis.
7. Subjects with serum AMH concentration\* below lower range norm.
8. Subjects with history of congestive heart disease NYHA stage III/IV.
9. Subjects with acute myocardial ischemia (CCS 3-4).
10. Subjects with history of sepsis or severe infection.
11. Subject with lung disease (uncontrolled asthma based on GINA 2000 Guidelines and COPD GOLD ≥ 3 stage).
12. Positive result of pregnancy test or pregnancy planned during the study.
13. Alcohol or other substance dependent syndromes.
14. BMI \<18.5 kg/m2.
15. Accompanying diseases with poor prognosis in the opinion of the researcher.
16. As per Investigator (or his designee) judgement, subject cannot participate in the study due to reasons (i.e. medical, psychiatric and/or social reason).
17. Unreliability or lack of cooperation. \*based on the laboratory results from screening visit

Where it's running

• Department of Endocrinology, Diabetology and Internal Medicine, Medical Univeristy of Bialystok
  Bialystok, Poland Recruiting
• Holy Cross Cancer Center
  Kielce, Świetokrzystie, Poland Recruiting

Study contacts

• Principal investigator: Agnieszka Adamska, Assoc.Prof. — Medical University of Bialystok
• Study coordinator: Agnieszka Adamska, Assoc.Prof.
• Email: methyr@umb.edu.pl, agnieszka.adamska@umb.edu.pl
• Phone: +48 85 746 86 07

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.