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

Not Applicable

Completed

• Conditions: Endometrium; Infertility, Female
• Interventions: Procedure: UC-MSCs therapy

• Registration Number: NCT03592849
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Study Start: 2018-09-10
• Primary Completion: 2021-01-31
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
endometrial thickness	12 months	endometrium thickness evaluated by transvaginal sonography during late proliferating phase

Secondary Outcome Measures

Name	Time	Method
endometrial blood flow	6 months	uterine blood flow evaluated by transvaginal sonography
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

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China