Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History
Recruiting · NCT06821685 · Interventional (participants receive a specific treatment) · Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
View the official record on ClinicalTrials.gov →Interventions studied
autologous decidual-like NK cells
What this trial is about
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.
Who can take part
Age range
22 Years to 40 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- The Affiliated Drum Tower Hospital of Nanjing University - Nanjing, Jiangsu, China