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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518670-13-00
Acronym
2021/ABM/03/00006
Enrollment
180
Registered
2024-12-13
Start date
2024-10-16
Completion date
Unknown
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic infertility

Brief summary

Obtaining a pregnancy during the study.

Detailed description

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., 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., 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.

Interventions

Sponsors

Medical University Of Bialystok
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Obtaining a pregnancy during the study.

Secondary

MeasureTime frame
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., Intrauterine metabolomic profiling of steroids w

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026