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NCT Number: NCT06821685

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

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.

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Key information

Age range

22 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

The Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210006, China

Location status: Recruiting

Location contact

Yali Hu

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

autologous decidual-like NK cells

Biological

intrauterine infusion

Primary outcomes

  1. Improvement rate of NK cells

    Time frame: 6 months after the first intrauterine infusion therapy

    Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells

Secondary outcomes

  1. Duration of improvement in NK cells

    Time frame: 6 months after the first intrauterine infusion therapy

    Duration of improvement in NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells

  2. Clinical pregnancy

    Time frame: 1 year after completion of NK cells therapy

    Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity

  3. Ongoing pregnancy

    Time frame: 1 year after completion of NK cells therapy

    At least 12 weeks of pregnancy, ultrasound indicates that the fetus has cardiac activity and the size of the fetus matches the gestational age

  4. Live birth

    Time frame: 1 year after completion of NK cells therapy

    Delivery of any number of neonates born at 26 or more weeks' gestation with signs of life

  5. preeclampsia

    Time frame: 1 year after completion of NK cells therapy

    The occurrence of preeclampsia during successful ongoing pregnancy after cell therapy

  6. fetal growth restriction

    Time frame: 1 year after completion of NK cells therapy

    The occurrence of fetal growth restriction during successful ongoing pregnancy after cell therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Zhu

CONTACT

[email protected]

86-025-83106666 ext. 54330

Yali Hu

CONTACT

[email protected]

86-025-83106666 ext. 11201

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Collaborators

  • The University of Science and Technology of China

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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