Using natural killer cells from patients to improve fertility and pregnancy outcomes

Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells

This study is testing whether using a special type of immune cell from patients can help improve fertility and pregnancy outcomes for those struggling with infertility or past pregnancy issues.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 22 Years to 40 Years
• Sex: Female
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06821685 on ClinicalTrials.gov

What this trial studies

This study explores the effectiveness of autologous decidual-like natural killer (NK) cells therapy in patients experiencing infertility or adverse pregnancy outcomes. Patients with abnormal uterine NK cell function will undergo menstrual blood analysis and, if eligible, will have their peripheral blood collected to isolate and culture NK cells. These cells will then be infused into the uterus, with continuous monitoring of NK cell function and subsequent pregnancy attempts over a six-month period. If necessary, patients may receive up to two treatments to enhance NK cell function.

Who should consider this trial

Good fit: Ideal candidates include women with abnormal uterine NK cell function and a history of recurrent pregnancy loss, repeated implantation failure, or unexplained infertility.

Not a fit: Patients with severe endometriosis, uterine fibroids, or other significant uterine abnormalities may not benefit from this therapy.

Why it matters

Potential benefit: If successful, this therapy could significantly improve fertility rates and pregnancy outcomes for patients with specific reproductive challenges.

How similar studies have performed: While this approach is innovative, similar studies exploring NK cell therapy have shown promise, indicating potential for success.

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.

Where this trial is running

Nanjing, Jiangsu

• The Affiliated Drum Tower Hospital of Nanjing University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Yali Hu — The Affiliated Drum Tower Hospital of Nanjing University
• Study coordinator: Yali Hu

Conditions Abortion, Habitual; Infertility Unexplained; Embryo Implantation; Pre-Eclampsia; recurrent pregnancy loss; repeated implantation failure; unexplained infertility; decidual natural killer cells