2024-518352-23-00Active, not recruitingPhase 3
Evaluation of metformin effect on the fertility of women treated with 131Ifor thyroid cancer
Evaluation of metformin effect on the fertility of women treated with 131I for thyroid cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Oct 2026
Brief summary (registry, in English)
To evaluate the efficacy of metformin on female fertility who were subjected to 131l treatment – ovarian reserve which is shown as AMH, inhibin B and FSH level in serum and antral follicle count checked by ultrasound
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 14 Oct 2024
- Start date
- 9 Nov 2022
- Lead sponsor
- Medical University Of Bialystok
- Diseases
- Thyroid cancer
- EU CT number
- 2024-518352-23-00
- EudraCT number
- 2021-005366-17
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 160
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hypersensitivity to metformin.
- 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).
- 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).
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.
Other
- Positive result of pregnancy test or pregnancy planned during the study.
- BMI <18.5 kg/m2.
- Unreliability or lack of cooperation.
- Subjects taking metformin during last week.
Who the study is looking for
- 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.
- Willingness to comply with protocol procedures.
Age in the registry: 18 years to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Poland | Active, not recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach | Kielce | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | Poland | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.