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Search / Trial NCT06821685

Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Feb 6, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Recurrent Pregnancy Loss Repeated Implantation Failure Unexplained Infertility Decidual Natural Killer Cells

ClinConnect Summary

This clinical trial is studying a new treatment called autologous decidual-like natural killer (NK) cells therapy, aimed at helping women who have had difficulties with pregnancy, such as repeated miscarriages or trouble getting pregnant. The therapy focuses on improving the function of certain immune cells in the uterus that may not be working properly. Researchers are looking for women aged 18 to 35 who have a history of abnormal uterine NK cell function and specific fertility issues, such as having had two or more miscarriages or multiple failed attempts at in vitro fertilization (IVF).

If you join the study, you will receive this specialized therapy, and researchers will monitor how well it works over time. To participate, you need to have normal ovarian function and a body mass index (BMI) between 18 and 30. However, there are some health conditions that might prevent you from taking part, such as severe endometriosis or uncontrolled autoimmune diseases. This trial is currently recruiting participants, and it aims to provide new insights into a potential treatment option for women facing challenges in their reproductive health.

Gender

FEMALE

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.

About The Affiliated Nanjing Drum Tower Hospital Of Nanjing University Medical School

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is a leading academic medical institution in China, renowned for its commitment to advanced healthcare, research, and medical education. As a prominent sponsor of clinical trials, the hospital leverages its state-of-the-art facilities and multidisciplinary expertise to facilitate innovative medical research aimed at improving patient outcomes. With a focus on translational medicine, the institution fosters collaborations between clinicians and researchers to accelerate the development of novel therapies and enhance the understanding of complex diseases. Through its rigorous adherence to ethical standards and regulatory compliance, the hospital is dedicated to advancing medical knowledge and contributing to the global scientific community.

Locations

Nanjing, Jiangsu, China

Patients applied

0 patients applied

Trial Officials

Yali Hu

Principal Investigator

The Affiliated Drum Tower Hospital of Nanjing University

Hui Zhu

Principal Investigator

The Affiliated Drum Tower Hospital of Nanjing University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported