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Clinical Trials/NCT03592849
NCT03592849
Completed
Not Applicable

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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country20 target enrollmentSeptember 10, 2018
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ConditionsInfertility, FemaleEndometrium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Female
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment
20
Locations
1
Primary Endpoint
endometrial thickness
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2018
End Date
August 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party
Principal Investigator
Principal Investigator

Yali Hu

Professor，Chief Physician of Obstetrics and Gynecology

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility Criteria

Inclusion Criteria

  • •Infertile patients with clear fertility desires
  • •Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective
  • •20-42 years old
  • •Normal ovarian function or with frozen embryos
  • •Willing to actively cooperate with postoperative follow-up

Exclusion Criteria

  • •With abnormal chromosome karyotype
  • •With other uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
  • •Systemic diseases: hypertension, diabetes, and so on
  • •Contraindications to pregnancy
  • •Contraindications to hormone replacement therapy
  • •Medical history of pelvic tumors or receiving pelvic radiotherapy
  • •Involved in other clinical studies
  • •Unable to adhere to the follow-up

Outcomes

Primary Outcomes

endometrial thickness

Time Frame: 12 months

endometrium thickness evaluated by transvaginal sonography during late proliferating phase

Secondary Outcomes

  • endometrial blood flow(6 months)
  • ongoing pregnancy rate(24 months)
  • live birth rate(24 months)

Study Sites (1)

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