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

Primary Purpose

Infertility, Female, Endometrium

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
UC-MSCs therapy
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring thin endometrium, infertility

Eligibility Criteria

20 Years - 42 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Nanjing Drum Tower Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UC-MSCs therapy

Arm Description

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

Outcomes

Primary Outcome Measures

endometrial thickness
endometrium thickness evaluated by transvaginal sonography during late proliferating phase

Secondary Outcome Measures

ongoing pregnancy rate
the presence of a living intrauterine fetus on TVU at the 12th week of gestation
live birth rate
a live born baby ≥28 weeks of gestation
endometrial blood flow
uterine blood flow evaluated by transvaginal sonography

Full Information

First Posted
July 9, 2018
Last Updated
September 27, 2022
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03592849
Brief Title
The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
Official Title
The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Endometrium
Keywords
thin endometrium, infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UC-MSCs therapy
Arm Type
Experimental
Arm Description
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring
Intervention Type
Procedure
Intervention Name(s)
UC-MSCs therapy
Other Intervention Name(s)
collagen scaffold
Intervention Description
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.
Primary Outcome Measure Information:
Title
endometrial thickness
Description
endometrium thickness evaluated by transvaginal sonography during late proliferating phase
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ongoing pregnancy rate
Description
the presence of a living intrauterine fetus on TVU at the 12th week of gestation
Time Frame
24 months
Title
live birth rate
Description
a live born baby ≥28 weeks of gestation
Time Frame
24 months
Title
endometrial blood flow
Description
uterine blood flow evaluated by transvaginal sonography
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
menstrual blood volume
Description
the change of menstrual blood volume after surgery compared with pre-operation
Time Frame
baseline and 6 month postoperation
Title
adverse event rate
Description
the occurrence of infections、allergies、abdominal pain postoperation
Time Frame
30 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yali Hu, MD,PhD
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Within six months after the trial complete

Learn more about this trial

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

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