Randomized, controlled, double-blind clinical trial evaluating the effect of METformin treatment on endometrial function in women diagnosed with Idiopathic Infertility

Phase 2

Recruiting

Conditions: idiopathic infertility

Registration Number: 2024-518670-13-00

Lead Sponsor: Medical University Of Bialystok

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Female

Target Recruitment: 180

Inclusion Criteria

Age ≥20≤40.

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.

Eligibility for the in vitro fertilization program.

Exclusion Criteria

Positive pregnancy test result.

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.

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.

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obtaining a pregnancy during the study.		Obtaining a pregnancy during the study.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effect of metformin therapy on endometrial function,assessed indirectly by blood tests of patients, will be examined by analyzing the concentrations of markers: cytokine(interleukin 1 and 2),insulin-like growth factor(IGF),leukemia inhibitory factor(LIF),transforming growth factor alpha(TGF-α),epidermal growth factor(EGF),heparin-binding growth factor-like EGF(HB-EGF),vascular endothelial growth factor(VEGF),histamine, inhibin B,relaxin and insulin receptor		Evaluation of the effect of metformin therapy on endometrial function,assessed indirectly by blood tests of patients, will be examined by analyzing the concentrations of markers: cytokine(interleukin 1 and 2),insulin-like growth factor(IGF),leukemia inhibitory factor(LIF),transforming growth factor alpha(TGF-α),epidermal growth factor(EGF),heparin-binding growth factor-like EGF(HB-EGF),vascular endothelial growth factor(VEGF),histamine, inhibin B,relaxin and insulin receptor
Analysis of the transcriptome of endometrial tissues using next-generation sequencing (NGS) technology to assess the effectiveness of increasing pregnancy rates in the in vitro fertilization procedure. The study will examine the full transcriptome, including a detailed microRNA profile. This will allow us to assess whether microRNAs, as regulators of gene expression, can act as predictive markers indicating the effectiveness of the in vitro fertilization procedure.		Analysis of the transcriptome of endometrial tissues using next-generation sequencing (NGS) technology to assess the effectiveness of increasing pregnancy rates in the in vitro fertilization procedure. The study will examine the full transcriptome, including a detailed microRNA profile. This will allow us to assess whether microRNAs, as regulators of gene expression, can act as predictive markers indicating the effectiveness of the in vitro fertilization procedure.
Intrauterine metabolomic profiling of steroids will be conducted to investigate whether metabolic analysis of these compounds can be used to identify potential prognostic markers. These markers could then be used to assess the effectiveness of increasing pregnancy rates in an in vitro fertilization procedure.		Intrauterine metabolomic profiling of steroids will be conducted to investigate whether metabolic analysis of these compounds can be used to identify potential prognostic markers. These markers could then be used to assess the effectiveness of increasing pregnancy rates in an in vitro fertilization procedure.
Effect of metformin treatment on regulation of oxidative stress. Increased production of reactive oxygen species (ROS) can negatively affect the implantation process. Metformin stimulates antioxidant processes and reduces the synthesis of ROS, which may contribute to the chance of embryo implantation in in vitro fertilization.		Effect of metformin treatment on regulation of oxidative stress. Increased production of reactive oxygen species (ROS) can negatively affect the implantation process. Metformin stimulates antioxidant processes and reduces the synthesis of ROS, which may contribute to the chance of embryo implantation in in vitro fertilization.
Analysis of the Quality of Life (QoL) questionnaire of patients undergoing the study and analysis of menus combined with DXA examination will provide key information to assess the impact of diet and lifestyle on the effectiveness of in vitro fertilization. The data collected will allow a holistic assessment of patients' health and well-being, which can have important implications for the effectiveness of treatment.		Analysis of the Quality of Life (QoL) questionnaire of patients undergoing the study and analysis of menus combined with DXA examination will provide key information to assess the impact of diet and lifestyle on the effectiveness of in vitro fertilization. The data collected will allow a holistic assessment of patients' health and well-being, which can have important implications for the effectiveness of treatment.

Trial Locations

Locations (2): Centrum Bocian Sp. z o.o. S.K.
🇵🇱
Bialystok, Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku
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Bialystok, Poland
Centrum Bocian Sp. z o.o. S.K.
🇵🇱Bialystok, Poland
Grzegorz Mrugacz
Site contact
+48602636656
gmrugacz@klinikabocian.pl