Status:
RECRUITING
Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
The University of Science and Technology of China
Conditions:
Abortion, Habitual
Infertility Unexplained
Eligibility:
FEMALE
22-40 years
Phase:
PHASE1
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 scree...
Eligibility Criteria
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.
Key Trial Info
Start Date :
February 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06821685
Start Date
February 13 2025
End Date
December 1 2027
Last Update
November 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210006