Autologous Decidual-like Natural Killer Cells Therapy for Reproductive Failure

Nanjing University

Status and phase

Not yet enrolling

Phase 2

Conditions

Infertility Unexplained

Abortion, Missed

Reproductive Disorder

Treatments

Biological: NK cell perfusion group

Study type

Interventional

Funder types

Other

Identifiers

NCT07230574

SC2025-0013-01

Details and patient eligibility

About

The aim of this study is to verify the efficacy of in vitro induction of autologous decidual-like NK cells therapy for reproductive failure associated with uterine NK cells abnormalities.

Full description

Participants with reproductive failure and reproductive intentions will be recruited and screened. After obtaining their informed consent, menstrual blood analysis will be performed. Participants with menstrual blood NK cell abnormalities will be randomly assigned to either the NK cell perfusion group or control group in a ratio of 2:1. After completing two rounds of NK cell therapy, the NK cell perfusion group will enter the follow-up period, while the control group will not receive interventions after randomization and enter the follow-up period directly. The following information will be recorded for all participants who undergo menstrual blood NK cell analysis, including menstrual blood analysis results, attempts to conceive, and pregnancy outcomes during the follow-up period.

Enrollment

159 estimated patients

Sex

Female

Ages

22 to 38 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Reproductive failure with abnormal endometrial natural killer (NK) cells in menstrual blood;
With a clear intention to conceive;
Normal ovarian function, or premature ovarian insufficiency with ≥2 high-quality cryopreserved embryos available for transfer;
Endometrial thickness measured by transvaginal ultrasound during the periovulatory period ≥7 mm;
Body mass index (BMI) between 18 kg/m² and 28 kg/m²;
Willing to comply with the follow-up plan of this study.

Exclusion criteria

Use of progesterone receptor modulators;
One of the couple's chromosomal karyotype abnormalities, with no euploid embryo identified via preimplantation genetic testing for aneuploidy;
Severe endometriosis or adenomyosis, uterine fibroids affecting uterine cavity morphology, uterine malformations, intrauterine adhesions, or thin endometrium;
Uncontrolled autoimmune or endocrine disorders;
Contraindications to pregnancy;
History of malignant tumors;
Participating in other clinical studies;
Allergy to blood products.