METFORMIN HYDROCHLORIDE for Idiopathic infertility

Inclusion criteria

• {"criterion_text":"- Age ≥20≤40."}
• {"criterion_text":"- No pregnancy for a minimum of 12 months prior to screening."}
• {"criterion_text":"- Diagnosed with idiopathic infertility."}
• {"criterion_text":"- No use of hormone therapy 30 days before screening."}
• {"criterion_text":"- No use of any methods of contraception 30 days before screening and during the examination."}
• {"criterion_text":"- BMI between 18.5 - 30 kg/m2."}
• {"criterion_text":"- Eligibility for the in vitro fertilization program."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Obtaining a pregnancy during the study.","definition_or_measurement_approach":"Not specified in the available record beyond the endpoint statement 'Obtaining a pregnancy during the study.'"}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measurement approach: blood tests analyzing concentrations of listed molecular markers (interleukins 1 and 2, IGF, LIF, TGF-α, EGF, HB-EGF, VEGF, histamine, inhibin B, relaxin, insulin receptor) as described in the endpoint text."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement approach: transcriptome analysis of endometrial tissues using NGS, including detailed microRNA profiling, to identify predictive markers."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement approach: intra-tissue metabolomic profiling of steroids to identify potential prognostic markers."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement approach: assessment of oxidative stress regulation (ROS levels and antioxidant markers) in endometrial tissue as described."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement approach: QoL questionnaire analysis and dietary/menu analysis combined with DXA examination to evaluate impact of diet and lifestyle."}

Poland

Earliest CTIS Part Ii Submission Date

07-11-2024

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

539

Number Of Sites

2

Number Of Participants

180

Primary sponsor

Full Name

Medical University Of Bialystok

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Cefea Sp. z o.o. S.K.","duties_or_roles":"Secondary packaging, manufacturing operations of investigational medicinal products","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Ko-Med Centra Kliniczne Sp. z o.o.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}