NCT05468554RecruitingPhase 3
Evaluation of Metformin Effect on the Fertility of Women Treated With 131I for Thyroid Cancer
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
This study is aimed to investigate the metformin effect on the fertility of women treated with 131 I for thyroid cancer
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 8 Jul 2022
- Start date
- 1 Nov 2022
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Medical University of Bialystok
- Diseases
- Thyroid cancer
- NCT number
- NCT05468554
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 160
- From 1 Nov 2022 to the primary completion date, 31 Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hypersensitivity to metformin.
- Subjects with polycystic ovarian syndrome or other diseases of the ovaries (primary / secondary ovarian failure).
- Subjects with lactic acidosis or having history of metabolic acidosis.
- 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).
- Alcohol or other substance dependent syndromes.
- 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).
Lab values
- Subjects with liver malfunction and abnormal hepatitis marker results (ALT and AST activity \>3ULN.\*
- Subjects with eGFR below 45ml/min/1.73m2.\*
- Subjects with serum AMH concentration\* below lower range norm.
- Unreliability or lack of cooperation. \*based on the laboratory results from screening visit
Other
- Subjects taking metformin during last week.
- Positive result of pregnancy test or pregnancy planned during the study.
- BMI \<18.5 kg/m2.
Who the study is looking for
- Female subjects in reproductive age \>18 \<45 years.
- Subjects with diagnosed papillary thyroid carcinoma with various pathological stage TNM (I-II).
- Subjects not treated with 131I
- Willingness to comply with protocol procedures.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology, Diabetology and Internal Medicine, Medical Univeristy of Bialystok Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Holy Cross Cancer Center Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.