Transplantation of hAMSCs for Woman With DOR

NCT ID: NCT04706312

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2024-04-30

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).

Conditions

Diminished Ovarian Response

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hAMSCs injection

hAMSCs were injected via venous in the dorsum of hand.

Group Type: EXPERIMENTAL

stem cells

Intervention Type: OTHER

hAMSCs injection via venous in the dorsum of hand

Interventions

stem cells

hAMSCs injection via venous in the dorsum of hand

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiayin Liu, Doctor

Role: STUDY_CHAIR

First Affiliated Hospital, Nanjing Medical University

Locations

Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Xiang Ma, Doctor

Role: CONTACT

sxmaxiang@126.com

+8618001581878

Lianju Qin, Doctor

Role: CONTACT

ljqin@njmu.edu.cn

+86 18012923584

Facility Contacts

Xiang Ma

Role: primary

8613770681878

Lianju Qin

Role: backup

8618012923584

Other Identifiers

2019-SCR-03

Identifier Type: -

Identifier Source: org_study_id