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| Name | Class |
|---|---|
| The University of Science and Technology of China | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NK cell perfusion group | Experimental | Accepting NK cell therapy |
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| Control group | No Intervention | Not accepting NK cell therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK cell perfusion group | Biological | Completing two rounds of NK cell therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of NK cells | Improvement rate of NK cells in menstrual blood analysis after intrauterine perfusion of autologous decidual-like NK cells | 6 months |
| Clinical pregnancy rate | Clinical pregnancy is defined as the presence of a gestational sac in the uterine cavity as indicated by ultrasound at 5-7 weeks of gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yali Hu | Contact | 86-025-83106666 | 11201 | glyyhuyali@163.com |
| Hui Zhu | Contact | 86-025-8310666 | 54330 | zhuhui1231@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yali Hu | The Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
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| ID | Term |
|---|---|
| D000030 | Abortion, Missed |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| The First Affiliated Hospital of Anhui Medical University |
| OTHER |
| The First Affiliated Hospital of University of Science and Technology of China | OTHER |
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| 6 months |
| Miscarriage rate | Miscarriage is defined as the pregnancy loss before 28 weeks of gestation | 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 | Preterm birth is defined as delivery at 28 to 37 weeks of gestation | 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 | Live birth is defined as delivery of any number of neonates born at 26 or more weeks' gestation with signs of life | 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 |