Clinical trial NCT06012682: Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
Official title: A Randomized, Controlled, Double-blind Study Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Infertility, Female
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
Collaborators: name: Medical Research Agency, Poland
First posted: 2023-08-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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


Eligibility criteria: Inclusion Criteria:

1. Age 18-45
2. No pregnancy for a minimum of 12 months prior to screening.
3. Diagnosed with idiopathic infertility.
4. No use of hormone therapy 30 days before screening.
5. No use of any methods of contraception 30 days before screening and during the examination.
6. BMI between 18.5 - 30 kg/m2.

Exclusion Criteria:

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

Primary outcomes:
measure: Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-hCG levels
timeFrame: 4 years
Secondary outcomes:
measure: Evaluation of the effect of metformin therapy on endometrial function.
timeFrame: 4 years
measure: Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology
timeFrame: 4 years
measure: Intra-tissue metabolic profiling of steroids
timeFrame: 4 years
measure: Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)
timeFrame: 4 years
measure: Quality of Life questionary evaluation SF-36, FertiQoL,
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
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