Abortion, Habitual, Embryo Implantation, Infertility Unexplained, Pre-Eclampsia
Conditions
Keywords
recurrent pregnancy loss, repeated implantation failure, unexplained infertility, decidual natural killer cells
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALautologous decidual-like NK cells
intrauterine infusion
Sponsors
The University of Science and Technology of China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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;
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement rate of NK cells | 6 months after the first intrauterine infusion therapy | Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 1 year after completion of NK cells therapy | Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity |
| Ongoing pregnancy | 1 year after completion of NK cells therapy | At least 12 weeks of pregnancy, ultrasound indicates that the fetus has cardiac activity and the size of the fetus matches the gestational age |
| Duration of improvement in NK cells | 6 months after the first intrauterine infusion therapy | Duration of improvement in NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells |
| preeclampsia | 1 year after completion of NK cells therapy | The occurrence of preeclampsia during successful ongoing pregnancy after cell therapy |
| fetal growth restriction | 1 year after completion of NK cells therapy | The occurrence of fetal growth restriction during successful ongoing pregnancy after cell therapy |
| Live birth | 1 year after completion of NK cells therapy | Delivery of any number of neonates born at 26 or more weeks' gestation with signs of life |
Countries
China
Contacts
Primary ContactYali Hu
Backup ContactHui Zhu
Outcome results
None listed