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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592849
Recruitment Status : Enrolling by invitation
First Posted : July 19, 2018
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility, Female Endometrium Procedure: UC-MSCs therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : January 31, 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility Scars
Drug Information available for: Collagen

Arms and Interventions
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Arm Intervention/treatment
Experimental: UC-MSCs therapy
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring
 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.
Other Name: collagen scaffold


Outcome Measures
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Primary Outcome Measures :
  1. endometrial thickness [ Time Frame: 12 months ]
    endometrium thickness evaluated by transvaginal sonography during late proliferating phase


Secondary Outcome Measures :
  1. ongoing pregnancy rate [ Time Frame: 24 months ]
    the presence of a living intrauterine fetus on TVU at the 12th week of gestation

  2. live birth rate [ Time Frame: 24 months ]
    a live born baby ≥28 weeks of gestation

  3. endometrial blood flow [ Time Frame: 6 months ]
    uterine blood flow evaluated by transvaginal sonography


Other Outcome Measures:
  1. menstrual blood volume [ Time Frame: baseline and 6 month postoperation ]
    the change of menstrual blood volume after surgery compared with pre-operation

  2. adverse event rate [ Time Frame: 30 months ]
    the occurrence of infections、allergies、abdominal pain postoperation


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592849


Locations
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China, Jiangsu
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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Principal Investigator: Yali Hu, MD,PhD The Affiliated Drum Tower Hospital of Nanjing University Medical School
More Information
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Responsible Party: Yali Hu, Professor，Chief Physician of Obstetrics and Gynecology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03592849    
Other Study ID Numbers: SC201700101
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Within six months after the trial complete

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
thin endometrium
infertility
Additional relevant MeSH terms:
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Infertility
Infertility, Female