Recruiting
Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History
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.
ClinicalTrials.gov IDNCT06821685
PhasePHASE1
Enrollment14
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Age22 Years – 40 Years
SexFEMALE
Conditions studied
Abortion, Habitual, Infertility Unexplained, Embryo Implantation, Pre-Eclampsia
About this study
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.
Interventions
- Biological: autologous decidual-like NK cells — intrauterine infusion
Primary outcomes
- Improvement rate of NK cells (6 months after the first intrauterine infusion therapy)
Eligibility information
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.
Study locations
- The Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu 210006 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.