Status:
NOT_YET_RECRUITING
Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
Lead Sponsor:
Medical University of Bialystok
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Infertility, Female
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief 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 grou...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patients with a history of congestive heart failure III/IV NYHA degree.
- 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.
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06012682
Start Date
August 30 2023
End Date
September 30 2027
Last Update
August 25 2023
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