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Study on the Effect of Metformin on Endometrial Function in Women with Unexplained Infertility

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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 women diagnosed with idiopathic infertility. Idiopathic infertility is a condition where a woman is unable to conceive, and the cause of infertility is unknown. The study aims to evaluate whether Metformin can improve the function of the endometrium, which is the lining of the uterus, and thereby enhance fertility in these women. Participants in the study will receive either Metformin or a placebo, which is a substance with no active medication, to compare the effects.

The study will be conducted over a period of time, during which participants will take the medication orally in the form of film-coated tablets. The primary goal is to observe if pregnancy occurs during the study. Additionally, the study will look at how Metformin affects various biological markers in the blood that are related to fertility, such as cytokines and growth factors. These markers can provide insights into how the endometrium is functioning and whether Metformin is having a positive effect.

Further analysis will include examining the genetic material in endometrial tissues to see if there are changes that could predict the success of in vitro fertilization (IVF). The study will also explore how Metformin might help reduce oxidative stress, which can affect embryo implantation. Participants' quality of life and lifestyle factors, such as diet, will also be assessed to understand their impact on the effectiveness of IVF. This comprehensive approach aims to provide a better understanding of how Metformin can support women with idiopathic infertility in achieving pregnancy.

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 study, you will attend an initial visit. During this visit, eligibility will be confirmed based on criteria such as age, diagnosis of idiopathic infertility, and other health factors.

    You will be informed about the study procedures, and any questions you have will be addressed. Consent will be obtained before proceeding.

  2. Step 2

    Randomization

    You will be randomly assigned to one of two groups. One group will receive the active medication, GLUCOPHAGE 500 mg (metformin hydrochloride), and the other group will receive a placebo.

    This process is double-blind, meaning neither you nor the study team will know which group you are in.

  3. Step 3

    Medication administration

    If you are in the active medication group, you will take GLUCOPHAGE 500 mg 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 and will be communicated to you during the trial.

  4. Step 4

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your health and the effects of the treatment. These visits will include blood tests to assess various markers related to endometrial function and fertility.

    Your overall health and any side effects will be closely monitored during these visits.

  5. Step 5

    Endometrial tissue analysis

    During the trial, an analysis of endometrial tissues may be conducted to evaluate the effectiveness of the treatment. This involves examining the tissue at a molecular level to understand changes in gene expression.

    This analysis will help assess the potential impact of the treatment on increasing pregnancy rates.

  6. Step 6

    Quality of life assessment

    You will complete a Quality of Life (QoL) questionnaire to provide information on how the treatment affects your daily life and well-being.

    This assessment, along with dietary and lifestyle analysis, will contribute to understanding the overall impact of the treatment.

  7. Step 7

    Study completion

    At the end of the study, a final evaluation will be conducted to assess the primary outcome, which is obtaining a pregnancy during the study.

    Secondary outcomes, such as changes in endometrial function and quality of life, will also be evaluated.

Who can join the trial?

7 criteria

  • Age between 20 and 40 years old.
  • No pregnancy for at least 12 months before the start of the study.
  • Diagnosed with idiopathic infertility (infertility with no known cause).
  • No use of hormone therapy 30 days before the start of the study.
  • No use of any methods of contraception 30 days before the start of the study and during the study.
  • BMI (Body Mass Index) between 18.5 and 30 kg/m2.
  • Eligible for the in vitro fertilization (IVF) program.

Who cannot join the trial?

4 criteria

  • Women who are not diagnosed with idiopathic infertility cannot participate. Idiopathic infertility means infertility with no known cause.
  • Men cannot participate in this study.
  • Women who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.
  • Individuals who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may be at a higher risk of harm or exploitation in a study.
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Investigated drugs

Metformin is a medication commonly used to treat type 2 diabetes. In this clinical trial, it is being tested to see if it can help improve the function of the lining of the uterus, known as the endometrium, in women who have unexplained infertility. The goal is to determine if taking metformin can increase the chances of becoming pregnant for these women by improving their fertility. Metformin works by helping the body use insulin more effectively, which can have various effects on the body, including potentially improving reproductive health.

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 to improve endometrial function in women with idiopathic infertility, which is infertility with no identifiable cause. Metformin works at the molecular level by improving the body's sensitivity to insulin, which can have various effects on cellular functions, including those related to fertility. It is classified as a biguanide, a type of medication that helps control blood sugar levels.

Investigated diseases

Idiopathic Infertility – Idiopathic infertility is a condition where a couple is unable to conceive after a year of regular, unprotected intercourse, and no specific cause for the infertility can be identified through standard medical evaluations. The progression of this condition is characterized by the continued inability to achieve pregnancy despite repeated attempts. It involves normal ovulation and sperm production, but the exact reasons for the lack of conception remain unknown. Over time, couples may experience increased emotional stress and frustration due to the uncertainty and lack of identifiable factors contributing to their infertility. The condition may persist indefinitely without intervention, as the underlying causes are not clearly understood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518670-13-00Protocol code2021/ABM/03/00006Estimated enrolment180 patientsSponsorAgencja Badań Medycznych

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