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Идёт набор NCT05181748

Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

Фаза II / Фаза III С лечением Poor Response to Ovulation Induction Infertility, Female Ovarian Insufficiency Ovarian Failure

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: Autologous platelet rich plasma.
Кому может быть актуально
Состояния в реестре: Poor Response to Ovulation Induction, Infertility, Female, Ovarian Insufficiency, Ovarian Failure. Базовые параметры: 35 лет — 47 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Греция
Следующий шаг
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Официальное название

Investigating the Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion on Improving Ovarian Functionality in Poor Ovarian Response Patients

Обзор

Autologous platelet rich plasma (PRP) intraovarian infusion may improve ovarian response to controlled ovarian stimulation as well as the hormonal profile of poor ovarian response infertile women subjected to intracytoplasmic sperm injection (ICSI) treatment.

Подробное описание

Despite recent advances in reproductive medicine, poor ovarian response (POR) management is still considered to be very challenging. Commonly, POR patients present with reduced ovarian reserve and poor ovarian stimulation performance. The POR cycles are characterized by a very limited number of retrieved oocytes, subsequently leading to poor embryo formation and thus to high cycle cancelation rate. Despite the fact that POR constitutes a multifactorial condition, it is well demonstrated that advanced maternal age (AMA) is the most significant contributor of POR. As maternal age increases, reduction of neo-angiogenesis in ovaries is observed, leading to accelerated follicular loss. Considering that PRP contains several growth factors such as vascular endothelial growth factor (VEGF) and cytokines, it has been proposed that intraovarian infusion of autologous PRP could restore the ovarian niche microenvironment, increasing ovarian response to external gonadotropin stimulation. However, limited data are available with regards to PRP efficiency in POR patients, which are mainly originating from pilot or small cohort studies. This interventional non-randomised open-label study aims to investigate the effect of autologous PRP intraovarian infusion on improving POR patient performance by studying a large and well-controlled POR population.

Вмешательства

  • Биопрепарат Autologous platelet rich plasma
    Preparation of PRP will be performed immediately following blood sample collection. Blood samples will be collected from the median antebrachial vein. PRP will be prepared according to the manufacturer's instructions employing a Regen Autologous Cellular Regeneration (ACR®-C) Kit (Regen Laboratory, Le Mont-sur-Lausanne, Switzerland). Approximately 60 mL of the patient's peripheral blood will be required in order to yield the required volume of PRP. The goal concentration of platelets in PRP is a

Первичные конечные точки

  • Number of oocytes retrieved [Срок оценки: 34-36 hours following ovulation triggering]
  • Anti-Müllerian Hormone Levels (AMH) [Срок оценки: On day 2-3 of the first menstrual cycle post intervention]
Вторичные конечные точки (2)
  • Clinical pregnancy rate [Срок оценки: 6-7 weeks following last menstruation]
  • Antral Follicle Count (AFC) [Срок оценки: On day 2-3 of the first menstrual cycle post intervention]

Критерии участия

Критерии включения

Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following):

  • Age ≥ 40 years
  • AMH < 1.1 ng/ml OR AFC < 7
  • ≤ 3 oocytes with a conventional stimulation protocol
  • Discontinuation of any complementary/adjuvant treatment including hormone replacement and acupuncture, for at least three months prior to recruitment.
  • Willing to comply with study requirements

Критерии исключения

  • Any pathological disorder related to reproductive system anatomy
  • Cycle irregularities
  • Amenorrhea
  • Endometriosis
  • Adenomyosis
  • Fibroids and adhesions
  • Infections in reproductive system
  • Current or previous diagnosis of cancer in reproductive system
  • History of familiar cancer in reproductive system
  • Severe male factor infertility
  • Prior referral for Preimplantation Genetic Testing (PGT) -Ovarian inaccessibility -Endocrinological disorders (Hypothalamus-
  • Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
  • BMI>30 kg/m2 or BMI<18.5 kg/m2
  • Systematic autoimmune disorders

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Греция · 1 центр
  • Genesis Athens Clinic — Athens

Идентификаторы

NCT: NCT05181748 · GenesisAC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗