Infertility
Conditions
Interventions
Intervention Group:Under ultrasound guidance, a transvaginal lateral wall puncture is performed to access both ovaries, with FGSCs injected into each ovary.Subjects will receive up to three intraovari
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Scheduled to undergo IVF-ET (in vitro fertilization and embryo transfer) at our center. 2) Female aged <= 45 years. 3) Good general health with no significant abnormalities in clinical examinations or laboratory tests (excluding ovarian function parameters). 4) AMH <= 0.7 ng/mL, meeting one of the following: Bilateral antral follicle count (AFC) <5, or <= 3 oocytes retrieved in a previous cycle. 5) Normal semen analysis of the male partner, or post-preparation sperm quality meeting standards for conventional IVF or intracytoplasmic sperm injection (ICSI). 6) Voluntarily participate in the study, commit to compliance with treatment protocols and follow-up schedules, and sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Abnormal karyotype in either partner; females with genetic abnormalities in meiotic homologous recombination-related genes, transcription factors, or hormone synthesis/receptor-related genes. 2. Female aged >45 years. 3. Pelvic pathologies including adenomyosis, uterine fibroids, endometrial polyps, scarred uterus, genital tuberculosis, hydrosalpinx, ovarian endometrioma, or tumors. 4. Acute reproductive tract infections or coagulation disorders in the female partner. 5. Active infectious diseases; uncontrolled chronic systemic conditions (e.g., hepatic/renal dysfunction, cardiac diseases), psychiatric disorders, malignancy history, or long-term aspirin use. 6. Definitively diagnosed autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome). 7. Known or unexplained causes of recurrent miscarriage. 8. History of malignancy requiring radiotherapy or chemotherapy. 9. Other medical/surgical conditions contraindicated for pregnancy. 10. Interventions for diminished ovarian reserve (DOR) within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Retrieved Oocytes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ovarian Reserve;fertilization rate (number of fertilized oocytes / number of retrieved oocytes);available embryo rate (number of D3 available embryos / number of embryos);Clinical pregnancy rate (number of pregnant cases which are confirmed by ultrasound/ total number of transplanted cases);Biochemical pregnancy rate (number of pregnant cases which are confirmed by blood ß-hCG examination / number of transplanted cases);implantation rate (number of gestational sacs / number of transplanted embryos);early miscarriage rate (number of miscarriage cases / number of pregnant cases confirmed by ultrasound);late miscarriage rate (number of miscarriage cases / number of pregnant cases confirmed by ultrasound);premature birth rate (number of premature births/ number of pregnant cases confirmed by ultrasound);live birth rate (number of deliveries / number of transplantation cycles); rate of adverse effect; | — |
Countries
China
Contacts
Public ContactBufang Xu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed