Autologous Decidual-like Natural Killer Cells Therapy for Reproductive Failure

Официальное название

A Prospective, Multicenter, Randomized Controlled Clinical Study on Autologous Decidual-like NK Cells Therapy for Reproductive Failure Associated With Abnormal Uterine Natural Killer Cells

Обзор

The aim of this study is to verify the efficacy of in vitro induction of autologous decidual-like NK cells therapy for reproductive failure associated with uterine NK cells abnormalities.

Подробное описание

Participants with reproductive failure and reproductive intentions will be recruited and screened. After obtaining their informed consent, menstrual blood analysis will be performed. Participants with menstrual blood NK cell abnormalities will be randomly assigned to either the NK cell perfusion group or control group in a ratio of 2:1. After completing two rounds of NK cell therapy, the NK cell perfusion group will enter the follow-up period, while the control group will not receive interventions after randomization and enter the follow-up period directly. The following information will be recorded for all participants who undergo menstrual blood NK cell analysis, including menstrual blood analysis results, attempts to conceive, and pregnancy outcomes during the follow-up period.

Вмешательства

• Биопрепарат NK cell perfusion group
  Completing two rounds of NK cell therapy

Первичные конечные точки

• Ongoing pregnancy rate [Срок оценки: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome]

Вторичные конечные точки (5)

• Improvement rate of NK cells [Срок оценки: 6 months]
• Clinical pregnancy rate [Срок оценки: 6 months]
• Miscarriage rate [Срок оценки: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome]
• Preterm birth rate [Срок оценки: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome]
• Live birth rate [Срок оценки: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome]

Критерии участия

Критерии включения

• Reproductive failure with abnormal endometrial natural killer (NK) cells in menstrual blood;
• With a clear intention to conceive;
• Normal ovarian function, or premature ovarian insufficiency with ≥2 high-quality cryopreserved embryos available for transfer;
• Endometrial thickness measured by transvaginal ultrasound during the periovulatory period ≥7 mm;
• Body mass index (BMI) between 18 kg/m² and 28 kg/m²;
• Willing to comply with the follow-up plan of this study.

Критерии исключения

• Use of progesterone receptor modulators;
• One of the couple's chromosomal karyotype abnormalities, with no euploid embryo identified via preimplantation genetic testing for aneuploidy;
• Severe endometriosis or adenomyosis, uterine fibroids affecting uterine cavity morphology, uterine malformations, intrauterine adhesions, or thin endometrium;
• Uncontrolled autoimmune or endocrine disorders;
• Contraindications to pregnancy;
• History of malignant tumors;
• Participating in other clinical studies;
• Allergy to blood products.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07230574 · SC2025-0013-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗