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

NCT ID: NCT06012682

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2027-09-30

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

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

patients randomized to received placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

group without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

metformin

patients randomized to received metformin

Group Type: EXPERIMENTAL

Metformin Hydrochloride

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Research Agency, Poland

OTHER_GOV

Sponsor Role: collaborator

Medical University of Bialystok

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Monika Zbucka-Krętowska, Associate Professor

Role: CONTACT

monika.zbucka-kretowska@umb.edu.pl

+48 85 831 87 89

Clinical Research Support Center

Role: CONTACT

owbk@umb.edu.pl

+48 85 686 53 86

Other Identifiers

2021/ABM/03/00006

Identifier Type: -

Identifier Source: org_study_id