Clinical trial NCT06821685: Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History
Official title: Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Abortion, Habitual
Infertility Unexplained
Embryo Implantation
Pre-Eclampsia
Keywords: recurrent pregnancy loss
repeated implantation failure
unexplained infertility
decidual natural killer cells
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: The University of Science and Technology of China
First posted: 2025-02-12
Enrollment: 14
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement rate of NK cells
timeFrame: 6 months after the first intrauterine infusion therapy
Secondary outcomes:
measure: Duration of improvement in NK cells
timeFrame: 6 months after the first intrauterine infusion therapy
measure: Clinical pregnancy
timeFrame: 1 year after completion of NK cells therapy
measure: Ongoing pregnancy
timeFrame: 1 year after completion of NK cells therapy
measure: Live birth
timeFrame: 1 year after completion of NK cells therapy
measure: preeclampsia
timeFrame: 1 year after completion of NK cells therapy
measure: fetal growth restriction
timeFrame: 1 year after completion of NK cells therapy
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
affiliation: The Affiliated Drum Tower Hospital of Nanjing University
name: Yali Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Drum Tower Hospital of Nanjing University
name: Hui Zhu
role: PRINCIPAL_INVESTIGATOR
References: