Abortion, Missed, Infertility Unexplained, Reproductive Disorder
Conditions
Keywords
Recurrent Pregnancy Loss, Repeated Implantation Failure, Unexplained Infertility, Decidual Natural Killer Cells
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.
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
BIOLOGICALNK cell perfusion group
Completing two rounds of NK cell therapy
Sponsors
The University of Science and Technology of China
Sir Run Run Shaw Hospital
Second Affiliated Hospital of Soochow University
The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of University of Science and Technology of China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 38 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement rate of NK cells | 6 months | Improvement rate of NK cells in menstrual blood analysis after intrauterine perfusion of autologous decidual-like NK cells |
| Clinical pregnancy rate | 6 months | 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 |
| 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 | Miscarriage is defined as the pregnancy loss before 28 weeks of gestation |
| 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 | Preterm birth is defined as delivery at 28 to 37 weeks of gestation |
| 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 | Live birth is defined as delivery of any number of neonates born at 26 or more weeks' gestation with signs of life |
Contacts
Primary ContactYali Hu
Backup ContactHui Zhu
Outcome results
None listed