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

Overview

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

• Biological autologous decidual-like NK cells
  intrauterine infusion

Primary outcome measures

• Improvement rate of NK cells [Time frame: 6 months after the first intrauterine infusion therapy]

Secondary outcome measures (6)

• Duration of improvement in NK cells [Time frame: 6 months after the first intrauterine infusion therapy]
• Clinical pregnancy [Time frame: 1 year after completion of NK cells therapy]
• Ongoing pregnancy [Time frame: 1 year after completion of NK cells therapy]
• Live birth [Time frame: 1 year after completion of NK cells therapy]
• preeclampsia [Time frame: 1 year after completion of NK cells therapy]
• fetal growth restriction [Time frame: 1 year after completion of NK cells therapy]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Affiliated Drum Tower Hospital of Nanjing University — Nanjing

Identifiers

NCT: NCT06821685 · 2024-LCYJ-PY-50

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗