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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112495
Enrollment
Unknown
Registered
2025-11-14
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reproductive failure

Interventions

Control group:No interventional treatment
Trial group:Intrauterine perfusion of autologous decidual-like NK cells

Sponsors

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
22 Years to 38 Years

Inclusion criteria

Inclusion criteria: 1. Reproductive failure with abnormal endometrial natural killer (NK) cells in menstrual blood; 2. With a clear intention to conceive; 3. Normal ovarian function, or premature ovarian insufficiency with =2 high-quality cryopreserved embryos available for transfer; 4. Endometrial thickness measured by transvaginal ultrasound during the periovulatory period =7 mm; 5. Body mass index (BMI) between 18 kg/m² and 28 kg/m²; 6. Willing to comply with the follow-up plan of this study.

Exclusion criteria

Exclusion criteria: 1. Use of progesterone receptor modulators; 2. One of the couple's chromosomal karyotype abnormalities, with no euploid embryo identified via preimplantation genetic testing for aneuploidy; 3. Severe endometriosis or adenomyosis, uterine fibroids affecting uterine cavity morphology, uterine malformations, intrauterine adhesions, or thin endometrium; 4. Uncontrolled autoimmune or endocrine disorders; 5. Contraindications to pregnancy; 6. History of malignant tumors; 7. Participating in other clinical studies; 8. Allergy to blood products.

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate;

Secondary

MeasureTime frame
Improvement rate of NK cells in menstrual blood;Clinical pregnancy rate;Miscarriage rate;Preterm birth rate;Live birth rate;

Countries

China

Contacts

Public ContactHu Yali

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

yalihu@nju.edu.cn+86 25 8310 6666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026