A Prospective, Multicenter, Randomized Controlled Clinical Study on Autologous Decidual-like NK Cells Therapy for Reproductive Failure Associated With Abnormal Uterine Natural Killer Cells
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 159
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NK cell perfusion group
Accepting NK cell therapy
干预措施: NK cell perfusion group (Biological)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 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
Ongoing pregnancy is defined as at least 12 weeks of gestation, with ultrasound indicating fetal cardiac activity and fetal size consistent with the gestational age
次要结局
- Improvement rate of NK cells(6 months)
- Clinical pregnancy rate(6 months)
- Miscarriage rate(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(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(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)
研究者
Yali Hu
M.D., Ph.D.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School