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Not yet recruiting NCT07230574

Autologous Decidual-like Natural Killer Cells Therapy for Reproductive Failure

Phase II Interventional Abortion, Missed Infertility Unexplained Reproductive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NK cell perfusion group.
Who it may be relevant to
Registry conditions: Abortion, Missed, Infertility Unexplained, Reproductive Disorder. Basic parameters: 22 years — 38 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multicenter, Randomized Controlled Clinical Study on Autologous Decidual-like NK Cells Therapy for Reproductive Failure Associated With Abnormal Uterine Natural Killer Cells

Overview

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.

Detailed 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.

Interventions

  • Biological NK cell perfusion group
    Completing two rounds of NK cell therapy

Primary outcome measures

  • Ongoing pregnancy rate [Time frame: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome]
Secondary outcome measures (5)
  • Improvement rate of NK cells [Time frame: 6 months]
  • Clinical pregnancy rate [Time frame: 6 months]
  • Miscarriage rate [Time frame: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome]
  • Preterm birth rate [Time frame: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome]
  • Live birth rate [Time frame: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome]

Eligibility criteria

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.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07230574 · SC2025-0013-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗