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
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.
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.
Parallel
Metformin Hydrochloride
DrugThe 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
DrugThe 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
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.
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.
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Medical University of Bialystok
Lead sponsor
Medical Research Agency, Poland
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
