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 MSC-like cell therapy in women suffering from POI.
The purpose of this work is to explore the safety and preliminary efficacy of human embryonic stem cell derived MSC-like cell transplantation in women with POI. MSC-like cells were injected directly into bilateral ovaries under transvaginal ultrasound. Patients are subjected into 3 groups, with low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells injection for each ovary. The outcomes of patients were followed after the injection every 2 weeks. The investigator mainly follow the safety indexes, and the level of sex hormone and signs of follicle growth will also be monitored. The growing follicles will be stimulated by exogenous hormone, followed by oocyte retrieval and in vitro fertilization (IVF).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Temperature
Body temperature of the participants will be measured fortnightly after injection.
Time frame: 0-24 weeks
Pulse
Pulse of the participants will be measured fortnightly after injection.
Time frame: 0-24 weeks
Breaths per minute
Breathing rate of the participants will be measured fortnightly after injection.
Time frame: 0-24 weeks
Blood pressure
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
Time frame: 0-24 weeks
Number of antral follicle
The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection.
Time frame: 0-24 weeks
Follicle-stimulating hormone (FSH) serum level
Serum FSH level will be tested fortnightly after injection.
Time frame: 0-24 weeks
Estradiol (E2) serum level
Serum E2 level will be tested fortnightly after injection.
Time frame: 0-24 weeks
Anti-Mullerian hormone (AMH) serum level
Serum AMH level will be tested fortnightly after injection.
Time frame: 0-24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ovarian volume
The ovarian volume will be recorded fortnightly by transvaginal ultrasound after injection.
Time frame: 0-24 weeks