Not Yet RecruitingPhase 2

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

200 participantsStarted 2023-08-30

Plain-language 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

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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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.

What they're measuring

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

Timeframe: 4 years

Trial details

NCT IDNCT06012682

SponsorMedical University of Bialystok

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Monika Zbucka-Krętowska, Associate Professor

+48 85 831 87 89 monika.zbucka-kretowska@umb.edu.pl

View on ClinicalTrials.gov More Infertility, Female trials