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

Infertility, Female Clinical Trial

— METIN  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06012682
• Other study ID #: 2021/ABM/03/00006
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 30, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: August 2023
• Source: Medical University of Bialystok
• Contact: Monika Zbucka-Kretowska, Associate Professor
• Phone: +48 85 831 87 89
• Email: monika.zbucka-kretowska[@]umb.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Metformin Hydrochloride
The investigational medicinal product/placebo will be dispensed to study participants by study staff during randomization visits V1, V2, V3, V4, V5 and V6. The randomized patient will receive the investigational medicinal product/placebo in tablets of 500 mg. The received tablets will be dispensed in an amount sufficient for the next visit. Patients will be asked to bring unused medicine and all empty ones packaging to the Center for each subsequent visit. The investigational medicinal product/placebo will be administered orally 500 mg three times a day (Table No. 1). The dose of the study product will be gradually increased from 500 mg/day to 1500 mg/day in order to avoid or reduce side effects related to taking the study medicinal product metformin
• Placebo
The investigational medicinal product/placebo will be dispensed to study participants by study staff during randomization visits V1, V2, V3, V4, V5 and V6. The randomized patient will receive the investigational medicinal product/placebo in tablets of 500 mg. The received tablets will be dispensed in an amount sufficient for the next visit. Patients will be asked to bring unused medicine and all empty ones packaging to the Center for each subsequent visit. The investigational medicinal product/placebo will be administered orally 500 mg three times a day (Table No. 1). The dose of the study product will be gradually increased from 500 mg/day to 1500 mg/day in order to avoid or reduce side effects related to taking the study medicinal product metformin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Bialystok	Medical Research Agency, Poland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and ß-hCG levels	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.	4 years
Secondary	Evaluation of the effect of metformin therapy on endometrial function.	It will be tested by assessing the concentration of biomarkers in the tissue before and after treatment	4 years
Secondary	Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology	Transcriptome analysis of endometrial tissues before and after metformin therapy.	4 years
Secondary	Intra-tissue metabolic profiling of steroids	The study will test whether treatment with metformin affects the intracrine production of steroid hormones in the endometrium.	4 years
Secondary	Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)	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.	4 years
Secondary	Quality of Life questionary evaluation SF-36, FertiQoL,	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.	24 weeks