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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Cgeqybl Bwwsjl Sib z oseu Sbca	Bialystok	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	20.03.2023

Trial locations

Investigated drugs:

Metformin Hydrochloride

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.

Investigated diseases:

Infertility female

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 ID:

2024-518670-13-00

Protocol code:

2021/ABM/03/00006

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?