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Набор скоро начнётся NCT07185984

Functional Development and Clinical Validation of a Diagnostic Tool Based on Artificial Intelligence for the Assessment of Sperm Quality and the Selection of the Optimal In Vitro Fertilisation (IVF) Treatment

— Наблюдательное Infertility (IVF Patients) Male Fertility Sperm Selection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Sperm sellection, DIAGNOSIS TOOL.
Кому может быть актуально
Состояния в реестре: Infertility (IVF Patients), Male Fertility, Sperm Selection. Базовые параметры: 18 лет — 50 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Infertility is a growing global health problem affecting millions of couples worldwide, with male infertility accounting for approximately half of all cases. In the physiological environment, sperm go through an exhaustive selection process in the female reproductive tract before reaching the oocyte. During this journey, progressive mobility and morphology are key parameters for achieving fertilisation. Therefore, before starting an assisted reproduction treatment, it is essential to analyse and process the semen sample to assess the fertile potential, select the most optimal sperm and determine the most appropriate treatment. Conventional methods of semen processing, such as density gradient centrifugation (DGC) and Swim-up washing of motile sperm, have significant limitations. These include interobserver and interlaboratory subjectivity, as well as damage to sperm DNA caused by centrifugation. Alternatively, microfluidics, which simulates natural selection, allows higher counts of morphologically normal, progressive motile sperm to be obtained. On the other hand, the CASA (computer-assisted sperm analysis) system has improved the standardisation and quality of semen analysis. Furthermore, the incorporation of Artificial Intelligence (AI) into semen quality analysis represents a promising opportunity, as it improves efficiency, accuracy and standardisation, and has the potential to increase success rates in assisted reproduction treatments. This project aims to develop an innovative AI-based diagnostic tool to address male infertility. The tool will integrate microfluidic technology and the CASA system to analyse semen quality, calculate fertilisation potential and recommend personalised treatments with an estimate of success. Trained with large volumes of biological and clinical data, it will provide a comprehensive and patient-specific diagnosis by identifying complex relationships between multiple variables. Finally, a comparative study will be conducted to evaluate laboratory indicators and clinical outcomes of cycles using this tool versus those using conventional methods.

Вмешательства

  • Диагностический тест Sperm sellection
    Small aliquots of 100 fresh human semen samples will be analysed using the SwimCount™ Harvester system, a CE-marked microfluidic technology patented by MCount and designed for routine clinical use.
  • Диагностический тест DIAGNOSIS TOOL
    The diagnostic tool developed will be validated by analyzing small aliquots of 100 additional fresh semen samples processed with the integrated microfluidic system (SwimCount™ Harvester) and the CASA system with artificial intelligence. To evaluate the diagnostic efficiency of the tool, the results obtained from the semen quality analysis will be compared with those obtained from the analysis of these samples when processed using the reference technique, based on conventional methods employed by

Первичные конечные точки

  • Development of a Male Infertility Diagnosis Tool [Срок оценки: 2 YEARS]
Вторичные конечные точки (2)
  • Prediction Capability Identification [Срок оценки: 2 Years]
  • Development of an AI algorithm [Срок оценки: 2 years]

Критерии участия

  • Inclusion criteria:
  • Men between the ages of 18 and 50 who come to the clinic to undergo an ICSI cycle.
  • Men between the ages of 18 and 50 who come to the clinic to undergo an artificial insemination cycle.
  • All embryos will be placed in a time-lapse incubator.
  • All women over 18 years of age who have obtained a MII number greater than or equal to 2 in oocyte retrieval, without excluding couples from the oocyte donation programme.
  • All men and women with a previously known normal karyotype.
  • Informed consent (IC) provided and signed by patients.
  • Exclusion criteria:
  • All women diagnosed with recurrent pregnancy loss.
  • All semen samples obtained by testicular biopsy.
  • All donor semen samples.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • IVI Valencia — Valencia

Идентификаторы

NCT: NCT07185984 · 2407-VLC-156-MM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗