Autologous Decidual-like Natural Killer Cells Therapy for Reproductive Failure

NCT07230574 | Not Yet Recruiting Phase 2

• 1 other identifier: SC2025-0013-01
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Abortion, Missed; Infertility Unexplained; Reproductive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  Ongoing pregnancy is defined as at least 12 weeks of gestation, with ultrasound indicating fetal cardiac activity and fetal size consistent with the gestational age

  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 Outcomes (5)

• Improvement rate of NK cells

  6 months

• Clinical pregnancy rate

  6 months

• Miscarriage rate

  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

  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

  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

Study Arms (2)

NK cell perfusion group

EXPERIMENTAL

Accepting NK cell therapy

Biological: NK cell perfusion group

Control group

NO INTERVENTION

Not accepting NK cell therapy

Interventions

NK cell perfusion group BIOLOGICAL

Completing two rounds of NK cell therapy

NK cell perfusion group

Eligibility Criteria

• Age: 22 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• The University of Science and Technology of China: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• The First Affiliated Hospital of University of Science and Technology of China: collaborator

MeSH Terms

Conditions

Abortion, Missed

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Yali Hu

  The Affiliated Drum Tower Hospital of Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yali Hu

CONTACT

86-025-83106666; glyyhuyali@163.com

Hui Zhu

CONTACT

86-025-8310666; zhuhui1231@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11