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Study on the Effect of Metformin on Fertility in Women with Thyroid Cancer Treated with Radioactive Iodine

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication metformin on the fertility of women who have been treated with radioactive iodine (131I) for papillary thyroid cancer. Metformin is commonly used to manage blood sugar levels in people with diabetes, but this study aims to explore its potential benefits on fertility. Participants in the study will either receive metformin or a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how metformin affects certain fertility indicators in women, such as hormone levels and the number of small follicles in the ovaries, which are checked using an ultrasound. The study will also look at how metformin might influence other factors like oxidative stress, which is an imbalance between free radicals and antioxidants in the body, and apoptosis, which is the process of programmed cell death. Additionally, the study will assess the quality of life of participants using a specific questionnaire designed for thyroid cancer patients.

Participants will be involved in the study over a period of time, attending several visits where these various factors will be measured and compared. The study will help to understand if metformin can improve fertility outcomes for women who have undergone treatment for papillary thyroid cancer, as well as its overall safety and tolerability in this group of patients.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the clinical trial, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as age and medical history related to papillary thyroid carcinoma.

    You will be informed about the trial procedures and asked to provide consent to participate.

  2. Step 2

    Randomization

    After the initial visit, you will be randomly assigned to one of two groups. One group will receive the medication metformin hydrochloride, and the other will receive a placebo.

    This process ensures that the study results are unbiased.

  3. Step 3

    Medication administration

    If you are in the metformin group, you will take GLUCOPHAGE 500 mg film-coated tablets orally. The dosage and frequency will be specified by the study team.

    The duration of medication administration will be determined by the study protocol.

  4. Step 4

    Scheduled visits

    You will attend several scheduled visits, labeled as V3, V4, V5, and V6. During these visits, various assessments will be conducted.

    These assessments include blood tests to measure hormone levels and ultrasound examinations to count antral follicles.

  5. Step 5

    Quality of life assessment

    Your quality of life will be evaluated using a specific questionnaire designed for patients with thyroid cancer.

    This assessment helps understand the impact of the treatment on your daily life.

  6. Step 6

    Monitoring and follow-up

    Throughout the trial, your health and any side effects will be closely monitored.

    Adjustments to the medication dosage may be made if necessary, based on your tolerance and any adverse effects experienced.

  7. Step 7

    End of trial

    At the end of the trial, a final evaluation will be conducted to assess the effects of the treatment.

    You will receive information about the study results and any further steps if needed.

Who can join the trial?

4 criteria

  • Participants must be female and between the ages of 18 and 45.
  • Participants must have been diagnosed with papillary thyroid carcinoma, which is a type of thyroid cancer.
  • Participants must not have been treated with 131I, which is a type of radioactive iodine treatment.
  • Participants must be willing to follow the study procedures as outlined in the protocol.

Who cannot join the trial?

5 criteria

  • Patients who are not diagnosed with papillary thyroid carcinoma cannot participate.
  • Only female patients are eligible; male patients cannot participate.
  • Patients who have not undergone 131I treatment (a type of radioactive iodine treatment) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. (The specific age range is not provided here.)
  • Patients who are considered part of a vulnerable population may not be eligible. (This typically refers to groups who may need special protection in research, such as children, pregnant women, or those with certain disabilities.)
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Investigated drugs

  • Metformin

    is a medication commonly used to help control blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being studied to see if it can improve fertility in women who have been treated with radioactive iodine, known as 131I, for thyroid cancer. The researchers are interested in understanding if metformin can help improve the health of the ovaries, which is measured by checking certain hormone levels in the blood and using ultrasound to look at the ovaries.

  • 131I (Radioactive Iodine)

    is a treatment used for thyroid cancer. It works by using a form of iodine that is radioactive to destroy cancer cells in the thyroid. In this trial, the focus is on women who have already received this treatment, and the researchers are looking at how it might affect their fertility. The study is exploring whether metformin can help improve fertility in these women after they have been treated with 131I.

What is already known about the treatment

Metformin – Metformin is typically taken orally in the form of a tablet. It is a well-established medication in the medical field, primarily used to manage blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being investigated for its potential effects on fertility in women who have been treated with radioactive iodine (131I) for thyroid cancer, specifically papillary thyroid carcinoma. Metformin works by improving the body's sensitivity to insulin and reducing the amount of sugar produced by the liver. It belongs to a class of drugs known as biguanides.

Investigated diseases

Papillary thyroid carcinoma – Papillary thyroid carcinoma is a type of cancer that arises from the thyroid gland, which is located in the neck. It is characterized by the formation of papillary structures in the thyroid tissue. This cancer typically grows slowly and often spreads to nearby lymph nodes. Despite its potential to spread, it usually remains localized in the thyroid region for a long time. Over time, it may cause symptoms such as a lump in the neck, difficulty swallowing, or changes in voice. The progression of the disease can vary, but it often remains manageable with appropriate medical care.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518352-23-00Protocol code2020/ABM/01/00100Estimated enrolment160 patientsSponsorAgencja Badań Medycznych

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