Climen 21 Tablets: Climen is commonly used clinically as a hormone replacement therapy and was administered to all patients in both the control and experimental groups in this project.
hA-MSCs: The patients who were part of the experimental group were administered oral Clomid medication in conjunction with a combined intravenous injection of human amniotic MSCs.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
20 Years
Max age
40 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Temperature — Up to 24 weeks Body temperature of the participants will be measured fortnightly after injection.
Pulse — up to 24 weeks Pulse of the participants will be measured fortnightly after injection.
Breaths per minute — up to 24 weeks Breathing rate of the participants will be measured fortnightly after injection.
Blood pressure — 0-24 weeks Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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