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

Primary Purpose

Infertility, Female

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Metformin Hydrochloride
Placebo
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    No Intervention

    Arm Label

    metformin

    placebo

    group without intervention

    Arm Description

    patients randomized to received metformin

    patients randomized to received placebo

    Outcomes

    Primary Outcome Measures

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

    Evaluation of the effect of metformin therapy on endometrial function.
    It will be tested by assessing the concentration of biomarkers in the tissue before and after treatment
    Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology
    Transcriptome analysis of endometrial tissues before and after metformin therapy.
    Intra-tissue metabolic profiling of steroids
    The study will test whether treatment with metformin affects the intracrine production of steroid hormones in the endometrium.
    Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)
    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.
    Quality of Life questionary evaluation SF-36, FertiQoL,
    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.

    Full Information

    First Posted
    June 22, 2023
    Last Updated
    August 22, 2023
    Sponsor
    Medical University of Bialystok
    Collaborators
    Medical Research Agency, Poland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06012682
    Brief Title
    Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
    Acronym
    METIN
    Official Title
    A Randomized, Controlled, Double-blind Study Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2027 (Anticipated)
    Study Completion Date
    September 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Bialystok
    Collaborators
    Medical Research Agency, Poland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Female

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    metformin
    Arm Type
    Experimental
    Arm Description
    patients randomized to received metformin
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    patients randomized to received placebo
    Arm Title
    group without intervention
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin Hydrochloride
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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 Outcome Measure Information:
    Title
    Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-hCG levels
    Description
    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.
    Time Frame
    4 years
    Secondary Outcome Measure Information:
    Title
    Evaluation of the effect of metformin therapy on endometrial function.
    Description
    It will be tested by assessing the concentration of biomarkers in the tissue before and after treatment
    Time Frame
    4 years
    Title
    Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology
    Description
    Transcriptome analysis of endometrial tissues before and after metformin therapy.
    Time Frame
    4 years
    Title
    Intra-tissue metabolic profiling of steroids
    Description
    The study will test whether treatment with metformin affects the intracrine production of steroid hormones in the endometrium.
    Time Frame
    4 years
    Title
    Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)
    Description
    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.
    Time Frame
    4 years
    Title
    Quality of Life questionary evaluation SF-36, FertiQoL,
    Description
    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.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Monika Zbucka-Krętowska, Associate Professor
    Phone
    +48 85 831 87 89
    Email
    monika.zbucka-kretowska@umb.edu.pl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clinical Research Support Center
    Phone
    +48 85 686 53 86
    Email
    owbk@umb.edu.pl

    12. IPD Sharing Statement

    Learn more about this trial

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

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