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Clinical study of autologous decidual-like NK cells in the treatment of recurrent abortion/repeated implantation failure

Clinical study of autologous decidual-like NK cells in the treatment of recurrent abortion/repeated implantation failure

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053633
Enrollment
Unknown
Registered
2021-11-26
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Recurrent spontaneous abortions/recurrent implantation failure

Interventions

Treatment group:Autologous decidual-like NK cells

Sponsors

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

Eligibility

Sex/Gender
Female
Age
22 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Aged 22 to 40 years, with clear fertility desires, but unexplained recurrent spontaneous abortions or repeated implantation failure that occurred before 12 weeks of pregnancy, and meet the following conditions: (1)Normal ovarian function or with frozen embryos; (2)Endometrium thickness measured by vaginal ultrasound before ovulation or at mid-luteal phase >= 7mm; 2.18 kg/m^2<BMI<30 kg/m^2; 3.With abnormal endometrial NK cells. (In this study, it is defined as the proportion of CD3-CD56+ natural killer cells (NK) in CD45+ lymphocytes in the menstrual blood of patients is less than 19.4%, which meets that the proportion of CD49a+NK cells in NK cells is less than 50% or the proportion of CD49a+CD16- NK is less than 40%); 4.Normal thyroid function; 5.Patients and their family members voluntarily participated in this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Severe immediate allergy to any types of drugs ; 2.In the period of using progesterone receptor modulator Asoprisnil or related drugs; 3.Chromosomal karyotype abnormalities in one spouse; 4.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; 5.Vaginitis and endometritis; 6.With autoimmune diseases, such as SLE, APS, etc.; 7.Abnormal blood coagulation function, abnormal liver and kidney function, or other basic diseases (uncontrolled hypertension, diabetes, thyroid disease, sexually transmitted diseases, etc.) that the researcher thought may affect the progress of the research; 8.History of pelvic malignant tumors or after receiving radiotherapy; 9.Bad habits such as smoking, alcohol abuse, excessive coffee drinking, drug abuse, etc. 10.Unfavorable environmental factors, such as excessive exposure to harmful chemical substances, excessive exposure to radiation, etc.; 11.Depression and other mental illnesses, having bad emotions, causing nervousness and negative emotions, depression, etc.; 12.Unable to adhere to the hospital examination and follow-up, or other treatment during the follow-up.

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate;Live birth rate;

Secondary

MeasureTime frame
Ratio of CD49a+ NK cells;

Countries

China

Contacts

Public ContactHu Yali

The Affiliated Drum Tower Hospital of Nanjing University Medical School

glyyhuyali@163.com+86 13951846008

Outcome results

None listed

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