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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03592849
Other study ID # SC201700101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2018
Est. completion date August 31, 2022

Study information

Verified date September 2022
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 31, 2022
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 42 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
UC-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.

Locations

Country Name City State
China Nanjing Drum Tower Hospital Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other menstrual blood volume the change of menstrual blood volume after surgery compared with pre-operation baseline and 6 month postoperation
Other adverse event rate the occurrence of infections?allergies?abdominal pain postoperation 30 months
Primary endometrial thickness endometrium thickness evaluated by transvaginal sonography during late proliferating phase 12 months
Secondary ongoing pregnancy rate the presence of a living intrauterine fetus on TVU at the 12th week of gestation 24 months
Secondary live birth rate a live born baby =28 weeks of gestation 24 months
Secondary endometrial blood flow uterine blood flow evaluated by transvaginal sonography 6 months
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