The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
After history taking, physical examination, ultrasound examination and hysteroscopy examination,infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory.
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
endometrial thickness
endometrium thickness evaluated by transvaginal sonography during late proliferating phase
Time frame: 12 months
ongoing pregnancy rate
the presence of a living intrauterine fetus on TVU at the 12th week of gestation
Time frame: 24 months
live birth rate
a live born baby ≥28 weeks of gestation
Time frame: 24 months
endometrial blood flow
uterine blood flow evaluated by transvaginal sonography
Time frame: 6 months
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