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Evaluation of metformin effect on the fertility of women treated with 131Ifor thyroid cancer
EU CTIS ID: 2024-518352-23-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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).
- Positive result of pregnancy test or pregnancy planned during the study.
- Alcohol or other substance dependent syndromes.
- BMI <18.5 kg/m2.
See the full eligibility 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.
- Willingness to comply with protocol procedures.
- 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).
- 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.
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.