Diminished Ovarian ResponsePhase 1NCT04706312
Transplantation of hAMSCs for Woman With DOR
A Phase 1 study testing stem cells in people with Diminished Ovarian Response, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Diminished Ovarian Response
- What is being tested?
- stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Apr 2021to Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
- Willing to sign the Informed Consent Form.
Who cannot join
- Patients diagnosed with hereditary, immunological and iatrogenic premature ovarian failure
- Patients allergy to blood products
- Patients diagnosed with abnormal coagulation function
- Patients diagnosed with uterine malformation
- Patients undergoing Preimplantation Genetic Testing
- Patients diagnosed with hydrosalpinx
Show all 11Show fewer
- Patients diagnosed with infectious diseases
- Contraindications for In Vitro Fertilization-Embryo Transfer(IVF-ET) or pregnancy
- Prior personal history of stem cell clinical trail or other clinical trails
- Unwilling to comply with study protocol
- Patients identified with high risk for stem cell injection
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Xiang Ma, 8613770681878
Lianju Qin, 8618012923584
About this study
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.
Read the 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
- Being tested
- stem cells
- Keywords
- Diminished ovarian response, human Amniotic Mesenchymal Stem Cells, Cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cellsOther
hAMSCs injection via venous in the dorsum of hand
| Study group | Role | What they receive |
|---|---|---|
| hAMSCs injection | Experimental | hAMSCs were injected via venous in the dorsum of hand. Receives: Other: stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Up to 12 months after first hAMSCs injection
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.
Measured: Up to 12 months after first hAMSCs injection
Secondary outcomes (2)
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.
Measured: Up to 12 months after first hAMSCs injection
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.
Measured: Up to 12 months after first hAMSCs injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study startApr 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ResponseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiayin Liu, Doctor, Study chair, First Affiliated Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706312
- Sponsor's protocol ID
- 2019-SCR-03
- Status last verified
- Feb 2021
- First submitted
- 10 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Assessment of Human Amniotic Mesenchymal Stem Cells(hAMSCs) Transplantation in Woman With Diminished Ovarian Reserve (DOR)
- ClinicalTrials.gov ID
- NCT04706312
- Acronym / sponsor ID
- 2019-SCR-03
- Conditions
- Diminished Ovarian Response
- Keywords
- Diminished ovarian response, human Amniotic Mesenchymal Stem Cells, Cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hAMSCs injection | Experimental | Other: stem cellshAMSCs were injected via venous in the dorsum of hand. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
- Willing to sign the Informed Consent Form.
Key exclusion criteria (11 listed)
- Patients diagnosed with hereditary, immunological and iatrogenic premature ovarian failure
- Patients allergy to blood products
- Patients diagnosed with abnormal coagulation function
- Patients diagnosed with uterine malformation
- Patients undergoing Preimplantation Genetic Testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stem cellshAMSCs injection via venous in the dorsum of hand | Other | hAMSCs injection |
Primary outcome
Safety and tolerability after hAMSCs injection.
Time frame: Up to 12 months after first 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 .
The ratio of transplantable embryo in DOR patients after hAMSCs injection.
Time frame: Up to 12 months after first hAMSCs injection
The ratio of transplantable embryo to normal fertilized embryos in DOR patients after hAMSCs injection.
2 secondary outcomes
Ovarian function in DOR patients after hAMSCs injection.
Time frame: Up to 12 months after first hAMSCs injection
Outcomes of IVF in DOR patients after hAMSCs injection.
Time frame: Up to 12 months after first hAMSCs injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiayin Liu, Doctor study chair
First Affiliated Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing stem cells in people with Diminished Ovarian Response, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Ma, Doctor (+8618001581878, sxmaxiang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability after hAMSCs injection. (time frame: Up to 12 months after first hAMSCs injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.