Actively Recruiting
Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
Led by Yan Hongli · Updated on 2025-08-11
50
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of human Amniotic mesenchymal stem cells (hA-MSCs) therapy in women suffering from POI.
CONDITIONS
Official Title
Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 20 to less than 40 years with normal karyotype
- Oligo/amenorrhea lasting at least 4 months
- Elevated FSH level greater than 25 IU/l on two occasions more than 4 weeks apart
- No history of stem cell therapy or hormone treatments within the previous 3 months
- Voluntary participation with signed informed consent
You will not qualify if you...
- Unable to follow the treatment observation process required by the trial
- Genetic diseases, chromosomal abnormalities, or genetic deficiencies causing POI
- Presence of breast, uterine, ovarian, or other benign or malignant tumors
- Allergic history to drugs or other substances
- Genetic disorders such as Turner's syndrome or congenital reproductive organ malformations
- Prior ovariectomy or organic gynecological diseases
- Other gynecological endocrine diseases such as polycystic ovary syndrome
- Severe functional impairment of vital organs
- High risk for venous thromboembolism or coagulation abnormalities
- Considered inappropriate for participation by attending doctor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changhai Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
H
Hongli Yan PhD, Professor, Reproductive Medici
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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