Premature Ovarian Insufficiency
Conditions
Keywords
hA-MSCs, Premature ovarian insufficiency
Brief 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.
Detailed description
This clinical trial is designed to understand the safety and effectiveness of human amniotic membrane mesenchymal stem cells (hA-MSCs) in the treatment of primary ovarian insufficiency (POI). Human amniotic MSCs were infused back into the patients by intravenous injection. The trial was designed with two groups, 1) the control group by conventional hormone replacement therapy with oral Climen and 2) the stem cell treatment group by intravenous infusion of human amniotic membrane mesenchymal stem cells (hA-MSCs) combined with oral Climen hormone therapy. Patients were followed up every 2 weeks after the post-injection stem cells to observe their outcomes. The investigators focused on safety indicators, but also monitored hormone levels and signs of follicular growth to initially assess the effectiveness of the stem cells.
Interventions
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.
BIOLOGICALhA-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.
Sponsors
Yan Hongli
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follicle-stimulating hormone (FSH) serum level | Up to 24 weeks | Serum FSH level will be tested fortnightly after injection. |
| Achievement of pregnancy | up to 12 months | A transvaginal ultrasound confirmation of gestational sac The hCG levels have reached between 1,000 - 2,000 mIU/mL. |
| Estradiol (E2) serum level | Up to 24 weeks | Serum E2 level will be tested fortnightly after injection. |
| Anti-Mullerian hormone (AMH) serum level | up to 24 weeks | Serum AMH level will be tested fortnightly after injection. |
| Number of antral follicle | up to 24 weeks | The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection. |
Countries
China
Contacts
Primary ContactHongli Yan PhD, Professor, Reproductive Medici
Outcome results
None listed