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Randomized, controlled, double-blind clinical trial evaluating the effect of METformin treatment on endometrial function in women diagnosed with Idiopathic Infertility
EU CTIS ID: 2024-518670-13-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥20≤40.
- 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.
You likely can't join if
- Positive pregnancy test result.
- 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.
- Patients diagnosed with another factor of infertility.
See the full eligibility criteria
- Age ≥20≤40.
- 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.
- Eligibility for the in vitro fertilization program.
- Positive pregnancy test result.
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.