Diminished Ovarian Response Clinical Trial
Official title:
The Safety and Efficacy Assessment of Human Amniotic Mesenchymal Stem Cells(hAMSCs) Transplantation in Woman With Diminished Ovarian Reserve (DOR)
Patients with Diminished ovarian response (DOR）have a poor in vitro fertilization（IVF） outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown promise in treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human Amniotic Mesenchymal Stem Cells(hAMSCs) in women suffered from infertility caused by DOR.
| Status | Not yet recruiting |
| Enrollment | 12 |
| Est. completion date | April 2024 |
| Est. primary completion date | January 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 35 Years to 45 Years |
| Eligibility | Inclusion Criteria: 1. Women between35 and 45 years, who is diagnosed with Diminished Ovarian Reserve by Bologna criteria, (AFC=7,or serum AMH level < 1.10ng/ml), and failed pregnancies in at least two cycles of In Vitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI). 2. Willing to sign the Informed Consent Form. Exclusion Criteria: 1. Patients diagnosed with hereditary, immunological and iatrogenic premature ovarian failure 2. Patients allergy to blood products 3. Patients diagnosed with abnormal coagulation function 4. Patients diagnosed with uterine malformation 5. Patients undergoing Preimplantation Genetic Testing 6. Patients diagnosed with hydrosalpinx 7. Patients diagnosed with infectious diseases 8. Contraindications for In Vitro Fertilization-Embryo Transfer(IVF-ET) or pregnancy 9. Prior personal history of stem cell clinical trail or other clinical trails 10. Unwilling to comply with study protocol 11. Patients identified with high risk for stem cell injection |
| Country | Name | City | State |
|---|---|---|---|
| China | Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and tolerability after hAMSCs injection. | Safety and tolerability assessed by Adverse Events and serious during injection and adverse events (SAEs) after injection assessed by long term follow-up . | Up to 12 months after first hAMSCs injection | |
| Primary | The ratio of transplantable embryo in DOR patients after hAMSCs injection. | The ratio of transplantable embryo to normal fertilized embryos in DOR patients after hAMSCs injection. | Up to 12 months after first hAMSCs injection | |
| Secondary | Ovarian function in DOR patients after hAMSCs injection. | Anti-müllerian Hormone (AMH) serum level, Follicle Stimulating Hormone (FSH) serum level, Estradiol (E2) serum level, Luteinizing Hormone (LH)serum level on menstrual day 2/3 will be evaluated after injection. The number of antral follicles will be recorded by transvaginal ultrasound scan. | Up to 12 months after first hAMSCs injection | |
| Secondary | Outcomes of IVF in DOR patients after hAMSCs injection. | The number of oocyte retrieval, fertilization rate , blastocyst formation rate, implantation rate, incidence of clinical pregnancy rate, after hAMSCs injection. | Up to 12 months after first hAMSCs injection |