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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
intrauterine infusion
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
RECRUITINGImprovement rate of NK cells
Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
Time frame: 6 months after the first intrauterine infusion therapy
Duration of improvement in NK cells
Duration of improvement in NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
Time frame: 6 months after the first intrauterine infusion therapy
Clinical pregnancy
Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity
Time frame: 1 year after completion of NK cells therapy
Ongoing pregnancy
At least 12 weeks of pregnancy, ultrasound indicates that the fetus has cardiac activity and the size of the fetus matches the gestational age
Time frame: 1 year after completion of NK cells therapy
Live birth
Delivery of any number of neonates born at 26 or more weeks' gestation with signs of life
Time frame: 1 year after completion of NK cells therapy
preeclampsia
The occurrence of preeclampsia during successful ongoing pregnancy after cell therapy
Time frame: 1 year after completion of NK cells therapy
fetal growth restriction
The occurrence of fetal growth restriction during successful ongoing pregnancy after cell therapy
Time frame: 1 year after completion of NK cells therapy
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