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NCT Number: NCT06012682

Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility

Randomized, controlled, double-blind, three-arm clinical trial in which 75 women will be randomized to treatment with metformin, 75 women to treatment with placebo and 50 women to the observation group. The medical intervention will last 24 weeks (6 months). Women with confirmed idiopathic infertility, in whom infertility factors have been excluded during full diagnostics, will be included in the study

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-45
  • No pregnancy for a minimum of 12 months prior to screening.
  • Diagnosed with idiopathic infertility.
  • No use of hormone therapy 30 days before screening.
  • No use of any methods of contraception 30 days before screening and during the examination.
  • BMI between 18.5 - 30 kg/m2.

Exclusion criteria

  • Positive pregnancy test result.
  • Patients diagnosed with another factor of infertility.
  • Patients with type I or II diabetes.
  • Patients taking metformin or other hypoglycaemic drugs in the last 4 weeks before screening.
  • Patients with hepatic impairment and abnormal liver function tests (alanine aminotransferase and/or aspartate aminotransferase (above 3x ULN).
  • Patients with an eGFR less than 45 mL/min/1.73m2.
  • Accompanying chronic diseases with poor prognosis.
  • Patients with a history of lactic acidosis or other metabolic acidosis.
  • Patients with a history of congestive heart failure III/IV NYHA degree.
  • Patients with acute myocardial ischemia.
  • Patients with sepsis or severe infection.
  • Diseases which, in the opinion of the investigator, constitute an exclusion criterion and prevent the patient from participating in the study.
  • Patients with predictable problems with cooperation with the research team.

Treatment and study plan

Metformin Hydrochloride

Drug

The investigational medicinal product/placebo will be dispensed to study participants by study staff during randomization visits V1, V2, V3, V4, V5 and V6.

The randomized patient will receive the investigational medicinal product/placebo in tablets of 500 mg. The received tablets will be dispensed in an amount sufficient for the next visit. Patients will be asked to bring unused medicine and all empty ones packaging to the Center for each subsequent visit. The investigational medicinal product/placebo will be administered orally 500 mg three times a day (Table No. 1). The dose of the study product will be gradually increased from 500 mg/day to 1500 mg/day in order to avoid or reduce side effects related to taking the study medicinal product metformin

Placebo

Drug

The investigational medicinal product/placebo will be dispensed to study participants by study staff during randomization visits V1, V2, V3, V4, V5 and V6.

The randomized patient will receive the investigational medicinal product/placebo in tablets of 500 mg. The received tablets will be dispensed in an amount sufficient for the next visit. Patients will be asked to bring unused medicine and all empty ones packaging to the Center for each subsequent visit. The investigational medicinal product/placebo will be administered orally 500 mg three times a day (Table No. 1). The dose of the study product will be gradually increased from 500 mg/day to 1500 mg/day in order to avoid or reduce side effects related to taking the study medicinal product metformin

Primary outcomes

  1. Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-hCG levels

    Time frame: 4 years

    The aim of the study is to evaluate the effect of metformin on endometrial function in women diagnosed with idiopathic infertility, by proving the use of the proposed therapy to improve fertility in these women.

Secondary outcomes

  1. Evaluation of the effect of metformin therapy on endometrial function.

    Time frame: 4 years

    It will be tested by assessing the concentration of biomarkers in the tissue before and after treatment

  2. Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology

    Time frame: 4 years

    Transcriptome analysis of endometrial tissues before and after metformin therapy.

  3. Intra-tissue metabolic profiling of steroids

    Time frame: 4 years

    The study will test whether treatment with metformin affects the intracrine production of steroid hormones in the endometrium.

  4. Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)

    Time frame: 4 years

    In-depth analysis of molecular and cellular processes using multi-omics combined with clinical data will provide essential knowledge about the mechanisms of metformin's action, which may have clinical applications not only in cases of idiopathic female infertility but also in other disorders.

  5. Quality of Life questionary evaluation SF-36, FertiQoL,

    Time frame: 24 weeks

    The results on the response scales are rotatable, summed and scaled from 0 to 100. Subscale and higher scores indicate good quality life. The number of obtained equation points is 50 or less arrangements with a psychologist.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Support Center

CONTACT

[email protected]

+48 85 686 53 86

Monika Zbucka-Krętowska, Associate Professor

CONTACT

[email protected]

+48 85 831 87 89

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Collaborators

  • Medical Research Agency, Poland

Registry information

Official study title

A Randomized, Controlled, Double-blind Study Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility

Acronym: METIN

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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