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Fut, nem toboroz3. fázis

Evaluation of metformin effect on the fertility of women treated with 131Ifor thyroid cancer

Key facts

Where
Bialystok, Kielce, Poznan és Warsaw, LengyelországSee the 4 sites
Phase
3. fázis

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?

Forrás: 2024-518352-23-00: ki vehet részt

Where in Lengyelország

  • Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, LengyelországNo longer taking part
  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielce, LengyelországNo longer taking part
  • Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, LengyelországNo longer taking part
  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, LengyelországNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Medical University Of Bialystok
Trial code
EU 2024-518352-23-00
Record updated
2026. október 30.
Original description
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 ultrasoundRead full original descriptionShow less

Evaluation of metformin effect on the fertility of women treated with 131I for thyroid cancer

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

Inclusion: 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.

Exclusion: 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); 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; 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.

EU CTIS 2024-518352-23-00