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

Phase 2

Not yet recruiting

• Conditions: Infertility, Female
• Interventions: Drug: Placebo; Drug: Metformin Hydrochloride

• Registration Number: NCT06012682
• Lead Sponsor: Medical University of Bialystok

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-22
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25
• Study Start: 2023-08-30
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	patients randomized to received placebo
metformin	Metformin Hydrochloride	patients randomized to received metformin

Primary Outcome Measures

Name	Time	Method
Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-hCG levels	4 years	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.

Secondary Outcome Measures

Name	Time	Method
Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology	4 years	Transcriptome analysis of endometrial tissues before and after metformin therapy.
Quality of Life questionary evaluation SF-36, FertiQoL,	24 weeks	The results on the response scales are rotatable, summed and scaled from 0 to 100. Subscale and higher scores indicate good quality life. The number of obtained equation points is 50 or less arrangements with a psychologist.
Evaluation of the effect of metformin therapy on endometrial function.	4 years	It will be tested by assessing the concentration of biomarkers in the tissue before and after treatment
Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)	4 years	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.
Intra-tissue metabolic profiling of steroids	4 years	The study will test whether treatment with metformin affects the intracrine production of steroid hormones in the endometrium.