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

Launched by MEDICAL UNIVERSITY OF BIALYSTOK · Jul 18, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how metformin, a medication commonly used for diabetes, might help improve fertility in women who have been treated for thyroid cancer with a specific radioactive treatment called 131I. The goal is to see if metformin can assist women aged 18 to 45 who have been diagnosed with a type of thyroid cancer known as papillary thyroid carcinoma and have not yet received the 131I treatment.

To participate in this study, women must meet certain criteria, such as being in the right age range and having a specific thyroid condition. However, there are some reasons why someone might not be able to join, like if they have certain medical conditions or are currently pregnant. If eligible, participants will follow the study protocol, and the researchers will monitor their health and fertility throughout the trial. It’s important to note that this study is not yet recruiting participants, so those interested will need to wait until it officially begins.

Gender

FEMALE

Eligibility 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.