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Not yet recruiting NCT06012682

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

Phase II Interventional Infertility, Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin Hydrochloride, Placebo.
Who it may be relevant to
Registry conditions: Infertility, Female. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • 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/
  • 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/

Primary outcome measures

  • Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-hCG levels [Time frame: 4 years]
Secondary outcome measures (5)
  • Evaluation of the effect of metformin therapy on endometrial function. [Time frame: 4 years]
  • Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology [Time frame: 4 years]
  • Intra-tissue metabolic profiling of steroids [Time frame: 4 years]
  • Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC) [Time frame: 4 years]
  • Quality of Life questionary evaluation SF-36, FertiQoL, [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06012682 · 2021/ABM/03/00006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗