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A Randomized, Open-label, Parallel-controlled Clinical Study of 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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women aged 20 to 40 years who have Primary Ovarian Insufficiency (POI), a condition where the ovaries stop functioning normally before age 40. This study aims to evaluate the safety of a new cell therapy using human amniotic mesenchymal stem cells (hA-MSCs) combined with hormone therapy. The trial compares this stem cell treatment to conventional hormone replacement therapy to better understand potential benefits for ovarian function. Participants are divided into two groups: one receives hormone replacement therapy with Climen tablets, and the other receives the same hormone therapy plus intravenous infusions of hA-MSCs. The stem cell group receives infusions on the third day after menstruation starts and again one month later. The Climen tablets are taken daily for seven days, followed by a seven-day break, repeated for two cycles. During the study, participants are monitored every two weeks for safety indicators like temperature, pulse, breathing rate, and blood pressure over 24 weeks. Researchers also measure hormone levels and follicle growth to assess treatment effects. Pregnancy outcomes will be followed for up to 12 months. The study is designed to closely track participant health and ovarian function throughout the trial period.
CONDITIONS
Brief 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 for 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 and no growth hormone and/or estrogen and progesterone therapy 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 premature ovarian insufficiency or failure
- Presence of breast, uterine, ovarian tumors, or any other benign or malignant tumors
- History of drug or other allergies
- Genetic disorders such as Turner's syndrome or congenital malformations of reproductive organs
- Previous ovariectomy or organic gynecological diseases
- Other gynecological endocrine diseases such as polycystic ovary syndrome
- Severe functional impairment of vital organs
- High risk factors for venous thromboembolism or coagulation abnormalities
- Deemed inappropriate to participate by attending doctor
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months
Participants receive hormone replacement therapy with Climen tablets. Those in the stem cell treatment group also receive two intravenous infusions of human amniotic mesenchymal stem cells, one initially and another one month later.
1 baseline visit and biweekly follow-up visits for up to 24 weeks
Duration - Up to 12 months
Participants are followed for safety and effectiveness assessments, including monitoring hormone levels and follicular growth.
Visits every 2 weeks after treatment for up to 24 weeks, with additional assessments for pregnancy outcomes up to 12 months
Trial Site Locations
Total: 1 location
1
Shanghai Changhai Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
H
Hongli Yan PhD, Professor, Reproductive Medici
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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