Endometrium, Infertility, Female
Conditions
Keywords
thin endometrium, infertility
Brief summary
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.
Interventions
PROCEDUREUC-MSCs therapy
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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
1. Infertile patients with clear fertility desires 2. Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective 3. 20-42 years old 4. Normal ovarian function or with frozen embryos 5. Willing to actively cooperate with postoperative follow-up
Exclusion criteria
1. With abnormal chromosome karyotype 2. With other uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis 3. Systemic diseases: hypertension, diabetes, and so on 4. Contraindications to pregnancy 5. Contraindications to hormone replacement therapy 6. Medical history of pelvic tumors or receiving pelvic radiotherapy 7. Involved in other clinical studies 8. Unable to adhere to the follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endometrial thickness | 12 months | endometrium thickness evaluated by transvaginal sonography during late proliferating phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ongoing pregnancy rate | 24 months | the presence of a living intrauterine fetus on TVU at the 12th week of gestation |
| live birth rate | 24 months | a live born baby ≥28 weeks of gestation |
| endometrial blood flow | 6 months | uterine blood flow evaluated by transvaginal sonography |
Other
| Measure | Time frame | Description |
|---|---|---|
| menstrual blood volume | baseline and 6 month postoperation | the change of menstrual blood volume after surgery compared with pre-operation |
| adverse event rate | 30 months | the occurrence of infections、allergies、abdominal pain postoperation |
Countries
China
Outcome results
None listed