Clinical trial NCT04706312: Transplantation of hAMSCs for Woman With DOR
Official title: The Safety and Efficacy Assessment of Human Amniotic Mesenchymal Stem Cells(hAMSCs) Transplantation in Woman With Diminished Ovarian Reserve (DOR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diminished Ovarian Response
Keywords: Diminished ovarian response, human Amniotic Mesenchymal Stem Cells, Cell therapy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 12
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 immense promise in the 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. The hAMSCs were isolated and cultured in vitro and qualified by National Institutes for Food and Drug Control, China. The serum of each patient was kept and sent for laboratory test before the transplantation. The biomarkers of hAMSCs were detected again before transplantation. The hAMSCs were transplanted via venous in the dorsum of hand. The outcomes of patients were examined during and after the injection. The patients are monitored for hormones, follicles stimulated with minimal stimulation, number of oocyte retrieval and embryos In Vitro Fertilization (IVF).

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability after hAMSCs injection.
timeFrame: Up to 12 months after first hAMSCs injection
measure: The ratio of transplantable embryo in DOR patients after hAMSCs injection.
timeFrame: Up to 12 months after first hAMSCs injection
Secondary outcomes:
measure: Ovarian function in DOR patients after hAMSCs injection.
timeFrame: Up to 12 months after first hAMSCs injection
measure: Outcomes of IVF in DOR patients after hAMSCs injection.
timeFrame: Up to 12 months after first hAMSCs injection
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital, Nanjing Medical University
name: Jiayin Liu, Doctor
role: STUDY_CHAIR
References: