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

NCT06012682 | Not Yet Recruiting Phase 2

• 1 other identifier: 2021/ABM/03/00006
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-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 Outcomes (5)

• Evaluation of the effect of metformin therapy on endometrial function.

  4 years

• Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology

  4 years

• Intra-tissue metabolic profiling of steroids

  4 years

• Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)

  4 years

• Quality of Life questionary evaluation SF-36, FertiQoL,

  24 weeks

Study Arms (3)

metformin

EXPERIMENTAL

patients randomized to received metformin

Drug: Metformin Hydrochloride

placebo

PLACEBO COMPARATOR

patients randomized to received placebo

Drug: Placebo

group without intervention

NO INTERVENTION

Interventions

Metformin Hydrochloride 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

metformin

Placebo 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

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45
• 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 may not qualify if:

• Positive pregnancy test result.
• 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.
• Patients with acute myocardial ischemia.
• Patients with sepsis or severe infection.
• Patients with predictable problems with cooperation with the research team.

Sponsors & Collaborators

• Medical University of Bialystok: lead
• Medical Research Agency, Poland: collaborator

MeSH Terms

Conditions

Infertility, Female

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Monika Zbucka-Krętowska, Associate Professor

CONTACT

+48 85 831 87 89; monika.zbucka-kretowska@umb.edu.pl

Clinical Research Support Center

CONTACT

+48 85 686 53 86; owbk@umb.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: August 25, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 25, 2023

Record last verified: 2023-08