Primary Ovarian Insufficiency
Conditions
Brief summary
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.
Interventions
BIOLOGICALPlacebo transplantation
Intraovarian injection of placebo through vagina under the guidance of ultrasonic.
BIOLOGICALHUC-MSCs transplantation
Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with primary ovarian insufficiency; 2. Women between 20 and 40 years; 3. Have fertility requirements, husband has sperm; 4. Willing to sign the Informed Consent Form.
Exclusion criteria
1. Primary amenorrhea; 2. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome); 3. Thyroid dysfunction; 4. Severe endometriosis; 5. Contraindications for pregnancy; 6. Prior personal history of ovarian cancer; 7. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period; 8. History of serious drug allergy or allergic constitution; 9. Autoimmune disease, history of severe familial genetic disease; 10. HIV+, hepatitis B, C;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of mature follicle | Up to 4 months | The number of mature follicles developing was recorded by transvaginal ultrasound scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follicle-stimulating hormone (FSH) serum level | Up to 4 months | Serum FSH level was evaluated once a month after surgery |
| Anti-Mullerian hormone (AMH) serum level | Up to 4 months | Serum AMH level was evaluated once a month after surgery |
| Estradiol (E2) serum level | Up to 4 months | Serum E2 level was evaluated once a month after surgery |
| Ovarian volume | Up to 4 months | The ovarian volume was recorded by transvaginal ultrasound scan |
| Pregnancy rate | Up to 12 months | The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection. |
| Number of antral follicle development | Up to 4 months | The number of antral follicles developing was recorded by transvaginal ultrasound scan |
Countries
China
Contacts
Primary ContactLong Yan, Doctor
Backup ContactJianqiao Liu, Doctor
Outcome results
None listed