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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
Completing two rounds of NK cell therapy
Ongoing pregnancy rate
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
Time frame: 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
Improvement rate of NK cells
Improvement rate of NK cells in menstrual blood analysis after intrauterine perfusion of autologous decidual-like NK cells
Time frame: 6 months
Clinical pregnancy rate
Clinical pregnancy is defined as the presence of a gestational sac in the uterine cavity as indicated by ultrasound at 5-7 weeks of gestation
Time frame: 6 months
Miscarriage rate
Miscarriage is defined as the pregnancy loss before 28 weeks of gestation
Time frame: 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
Preterm birth is defined as delivery at 28 to 37 weeks of gestation
Time frame: 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
Live birth is defined as delivery of any number of neonates born at 26 or more weeks' gestation with signs of life
Time frame: 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
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