Human amniotic mesenchymal stem cell treatment for premature ovarian insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional trial compares standard oral hormone replacement (Climen) alone versus Climen plus an intravenous infusion of human amniotic mesenchymal stem cells (hA-MSCs). Participants are women aged 20–40 with documented premature ovarian insufficiency and elevated FSH, who are followed every two weeks after infusion for safety monitoring and hormone measurements. The primary focus is safety, with secondary observations of hormone levels and signs of follicular growth to provide an initial signal of effectiveness. The trial uses a control group receiving conventional hormone therapy to contextualize any changes seen after stem cell infusion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The intention of pregnant women aged \>= 20 and \< 40, with normal karyotype;
2. Oligo/amenorrhea for at least 4 months;
3. Elevated FSH level \>25 IU/l on two occasions \>4 weeks apart;
4. Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;
5. Voluntary participation in the study with signed informed consent;

Exclusion Criteria:

1. Unable to follow the treatment observation process required by the trial;
2. Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;
3. With breast, uterine, ovarian tumors, or any other benign or malignant tumors;
4. Allergic history to drugs or any other things;
5. Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.
6. Have undergone ovariectomy or have organic gynaecological diseases.
7. Presence of other gynaecological endocrine diseases such as polycystic ovary syndrome.
8. Severe functional impairment of vital organs.
9. High risk factors for venous thromboembolism and abnormalities in coagulation mechanisms.
10. Attending doctor considers inappropriate to take part in.

Where it's running

• Shanghai Changhai Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Hongli Yan PhD, Professor, Reproductive Medici
• Email: hongliyan@smmu.edu.cn
• Phone: 021-31162338

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.