The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring

Nanjing University

Status: Completed

Conditions: Endometrium; Infertility, Female

Treatments: Procedure: UC-MSCs therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03592849

SC201700101

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

UC-MSCs therapy

Experimental group

Description:

transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring

Treatment:

Procedure: UC-MSCs therapy