Recurrent implant failure
Conditions
Interventions
experimental group:Telpefilgrastim injection
Sponsors
The Second Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Subjects are able to understand and comply with the content, requirements, and restrictions of the protocol, can complete the study according to the protocol requirements, and fully understand the possible adverse reactions, voluntarily signing the informed consent form before the trial. 2. Age is between 20 and 40 years old (including 20 and 40 years old). 3. Adult women under 40 years old who have not achieved a clinical pregnancy after transferring at least 3 high-quality embryos in 2 fresh or frozen cycles, where high-quality embryos include: Day 3 embryos (with a cell count of >=8, uniform blastomere size, and a fragmentation rate of =3BB). 4. The body mass index (BMI) at screening is between 19 and 30. 5. Patients planning to undergo frozen blastocyst transfer in in vitro fertilization (IVF) cycles. 6. Have at least one blastocyst remaining.
Exclusion criteria
Exclusion criteria: 1. Combined with other factors affecting embryo implantation (chronic endometritis, uterine anatomical abnormalities, hydrosalpinx, history of severe intrauterine adhesion separation, adenomyosis, endometriosis stage III or above), etc.; 2. Clearly suffering from autoimmune diseases or pre-thrombotic states; 3. Clearly diagnosed with thyroid dysfunction or diabetes; 4. Presence of uncontrolled infections, including evidence of HIV, HBV (positive for HBsAg), HCV (positive for anti-HCV antibodies), syphilis, and positive TORCH screening, chronic endometritis, bacterial vaginosis, reproductive tract dysbiosis, and severe infections accompanied by bacteremia or viremia, etc.; 5. Suffering from malignant tumors or any history of malignant tumors within 5 years before screening (except for completely excised cervical carcinoma in situ or non-metastatic squamous cell carcinoma or basal cell carcinoma of the skin) and/or hematological diseases; 6. Patients with congestive heart failure (NYHA class II to IV), myocardial infarction, unstable angina, or severe heart disease in the past or present within 6 months before enrollment; 7. Severe cerebrovascular diseases within 6 months before enrollment; 8. Significant pulmonary diseases assessed by the researcher at the time of screening; 9. History of organ transplantation, use of immunosuppressants within the past 3 months or planned use, including but not limited to: calcineurin inhibitors such as tacrolimus and cyclosporine; mycophenolate mofetil and mycophenolate sodium enteric-coated tablets; glucocorticoids such as prednisone and methylprednisolone; others such as sirolimus, azathioprine, mycophenolate mofetil, and leflunomide, etc.; 10. History of poorly controlled mental illness; 11. Severe hypertension (systolic pressure >= 180 mmHg or diastolic pressure >= 110 mmHg) or poorly controlled hypertension after antihypertensive drug treatment (systolic pressure >= 160 mmHg or diastolic pressure >= 90 mmHg) or malignant hypertension, hypertensive emergency, hypertensive urgency, etc.; 12. The following laboratory abnormalities at the time of screening or within 3 months before screening: thrombocytopenia or thrombocytosis (platelet count 500,000/µL), neutropenia or neutrophilia (absolute neutrophil count 10,000/µL), leukopenia or leukocytosis (white blood cell count 15,000/µL), severe liver disease patients or liver dysfunction (ALT or AST >2×ULN), renal impairment, creatinine (Cr) >1.5×ULN; 13. Allergic to rhG-CSF products (including rhG-CSF and PEGylated rhG-CSF) and their components, or allergic to recombinant human proteins or polypeptide drugs derived from E. coli; 14. Use of granulocyte-stimulating factor drugs within 3 months before screening; planned or current use of drugs with potential drug interactions with granulocyte-stimulating factor drugs, such as lithium; 15. Current or planned use of immunoglobulins (IVIG), fat emulsions, lymphocyte active immunotherapy (LIT), tumor necrosis factor-a (TNF-a) inhibitors, peripheral blood mononuclear cell (PBMC) transfusions, and/or any other drugs that the researcher believes may affect the mechanism of repeated implantation failure; 16. History of drug abuse, drug use, or alcoholism with clinical symptoms (history of drug abuse or drug use in the past five years; consumption of 14 units of alcohol per week: 1 unit = beer 285 mL, or spirits 25 mL, or wine 100 mL); 17. Smoking (or use of tobacco-containing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Pharmacokinetics parameters of Telpefilgrastim injection;Pharmacodynamics parameters of Telpefilgrastim injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive rate of HCG;Embryo implantation rate;Clinical pregnancy rate; | — |
Countries
China
Contacts
Public ContactTang Li
The Second Affiliated Hospital of Zhengzhou University
Outcome results
None listed