Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History

Официальное название

Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells

Обзор

The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.

Подробное описание

Menstrual blood analysis will be performed on patients with infertility or a history of adverse pregnancy outcomes who have fertility needs. Those with abnormal uterine NK cells function will be screened and given informed consent forms pre-treatment. Collecting peripheral blood from the patients, isolating and inducing in vitro culture to obtain autologous decidual like NK cells which will be perfused into their uterine. Perform continuous menstrual blood analysis within 6 months after the first treatment to assess the improvement of uterine NK cell function. If the function of uterine NK cells improves, enter the stage of attempting pregnancy and follow up pregnancy outcomes; If the function of uterine NK cells does not improve, then autologous decidual like NK cells uterine cavity perfusion therapy will be performed again. NK cells intrauterine infusion will be treated up to 2 times.

Вмешательства

• Биопрепарат autologous decidual-like NK cells
  intrauterine infusion

Первичные конечные точки

• Improvement rate of NK cells [Срок оценки: 6 months after the first intrauterine infusion therapy]

Вторичные конечные точки (6)

• Duration of improvement in NK cells [Срок оценки: 6 months after the first intrauterine infusion therapy]
• Clinical pregnancy [Срок оценки: 1 year after completion of NK cells therapy]
• Ongoing pregnancy [Срок оценки: 1 year after completion of NK cells therapy]
• Live birth [Срок оценки: 1 year after completion of NK cells therapy]
• preeclampsia [Срок оценки: 1 year after completion of NK cells therapy]
• fetal growth restriction [Срок оценки: 1 year after completion of NK cells therapy]

Критерии участия

Критерии включения

• abnormal uterine NK cell function;
• have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;
• have clear fertility desires;
• normal ovarian function or with frozen embryos;
• edometrium thickness measured by vaginal ultrasound before ovulation or at mid-luteal phase >= 7mm;
• 18kg/m\^2 < Body mass index < 30kg/m\^2;

Критерии исключения

• using progesterone receptor modulator;
• chromosomal karyotype abnormalities in one spouse;
• severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;
• uncontrolled autoimmune diseases;
• abnormal blood coagulation function, abnormal liver and kidney function, or other uncontrolled basic diseases (hypertension, diabetes, thyroid disease, etc.) that the researcher access which may affect the progress of the study;
• history of pelvic malignant tumors;
• currently participating in other clinical studies;
• allergic to blood products.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Affiliated Drum Tower Hospital of Nanjing University — Нанкин

Идентификаторы

NCT: NCT06821685 · 2024-LCYJ-PY-50

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗