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

NCT ID NCT05468554

Sponsor: Medical University of Bialystok Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 21, 2026 · Last updated Oct 22, 2026 · Updated 1 time

Summary

This study is aimed to investigate the metformin effect on the fertility of women treated with 131 I for thyroid cancer

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female subjects in reproductive age \>18 \<45 years. 2. Subjects with diagnosed papillary thyroid carcinoma with various pathological stage TNM (I-II). 3. Subjects not treated with 131I 4. Willingness to comply with protocol procedures. Exclusion Criteria: 1. Hypersensitivity to metformin. 2. Subjects with polycystic ovarian syndrome or other diseases of the ovaries (primary / secondary ovarian failure). 3. Subjects taking metformin during last week. 4. Subjects with liver malfunction and abnormal hepatitis marker results (ALT and AST activity \>3ULN.\* 5. Subjects with eGFR below 45ml/min/1.73m2.\* 6. Subjects with lactic acidosis or having history of metabolic acidosis. 7. Subjects with serum AMH concentration\* below lower range norm. 8. Subjects with history of congestive heart disease NYHA stage III/IV. 9. Subjects with acute myocardial ischemia (CCS 3-4). 10. Subjects with history of sepsis or severe infection. 11. Subject with lung disease (uncontrolled asthma based on GINA 2000 Guidelines and COPD GOLD ≥ 3 stage). 12. Positive result of pregnancy test or pregnancy planned during the study. 13. Alcohol or other substance dependent syndromes. 14. BMI \<18.5 kg/m2. 15. Accompanying diseases with poor prognosis in the opinion of the researcher. 16. As per Investigator (or his designee) judgement, subject cannot participate in the study due to reasons (i.e. medical, psychiatric and/or social reason). 17. Unreliability or lack of cooperation. \*based on the laboratory results from screening visit

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Conditions

The condition(s) this trial relates to.

thyroid cancer Thyroid Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thyroid cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Endocrinology, Diabetology and Internal Medicine, Medical Univeristy of Bialystok

    RECRUITING

    Bialystok, 15-276, Poland

  • Holy Cross Cancer Center

    RECRUITING

    Kielce, Świetokrzystie, 25-734, Poland

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