Clinical trial · Interventional
Evaluation of Metformin Effect on the Fertility of Women Treated With 131I for Thyroid Cancer
NCT05468554CI-TRIAL-00061540METHYRunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is aimed to investigate the metformin effect on the fertility of women treated with 131 I for thyroid cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin | Drug | Metformin | ALIAS |
| Radioactive iodine (I-131) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- patients qualified to receive metformin and 131I treatment
- interventionNames
- Drug: metformin
- Radiation: Radioactive iodine (I-131)
- type
- ACTIVE_COMPARATOR
- label
- Placebo
- description
- patients receiving placebo and 131 I treatment
- interventionNames
- Radiation: Radioactive iodine (I-131)
- type
- NO_INTERVENTION
- label
- Observational
- description
- observation group, patients after thyroidectomy, characterized by low risk of cancer progression, in this case, not qualified for 131I treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.