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Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells

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ClinicalTrials.gov Identifier: NCT02204358
Recruitment Status : Unknown
Verified July 2014 by Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Recruiting
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Tracking Information
First Submitted Date  ICMJE July 26, 2014
First Posted Date  ICMJE July 30, 2014
Last Update Posted Date July 30, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
Reduction of intrauterine scar area,the change of intrauterine adhesion [ Time Frame: up to 3 months ]
hysteroscope ,understanding improvement of uterine cavity form,the degree and nature of adhesion or the vanishment of intrauterine adhesion,and the reduction of scar and its area,comparing with pre-operation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
  • The change of endometrial thickness [ Time Frame: up to 1 month ]
    Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.
  • The change of endometrial thickness [ Time Frame: up to 2 months ]
    Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.
  • menstrual blood volume The change of menstrual blood volume [ Time Frame: baseline and 1 month ]
    Understanding the menstrual blood volume after surgery ,the number of sanitary napkins per day ,and number of days,comparing with pre-operation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 28, 2014)
rate of pregnancy [ Time Frame: 2 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells
Official Title  ICMJE Clinical Study of the Treatment of Infertility Caused by Severe Intrauterine Adhesions by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells
Brief Summary Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide clinical evidence for the treatment of uterine infertility
Detailed Description Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is no effective treatment to the infertility caused by severe intrauterine adhesions or endometrial dysplasia which affects embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe intrauterine adhesions.Collagen is the main component of the extracellular matrix with good biocompatibility, and it has been approved for the reparation of skin and oral mucosa by State Food and Drug Administration. Bone marrow stem cells have been used in the clinical treatment of blood diseases, and achieved good results. In this study, collagen scaffold and autologous bone marrow stem cells are combined, and they showed good biological safety
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infertility
  • Intrauterine Adhesions
  • Endometrial Dysplasia
Intervention  ICMJE Procedure: autologous bone marrow stem cells

Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.

If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.

Other Names:
  • infertility
  • severe intrauterine adhesions
  • endometrial dysplasia
  • collagen scaffold
Study Arms  ICMJE Experimental: autologous bone marrow stem cells
Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.
Intervention: Procedure: autologous bone marrow stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 28, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infertility caused by serious intrauterine adhesions or endometrial dysplasia
  • Hysteroscopy examination confirmed intrauterine adhesions or endometrial dysplasia
  • Monitoring of endometrial cycle
  • Sign a consent form
  • Follow the test plan and follow-up process

Exclusion Criteria:

  • Abnormal chromosome karyotype
  • Congenital uterine malformations
  • Severe endometriosis
  • Severe adenomyosis
  • Contraindications to pregnancy
  • Contraindications to bone marrow collection
  • Contraindications to hormone replacement therapy
  • Medical history of pelvic tumors or receiving pelvic radiotherapy
  • Unable to adhere to the hospital examination and follow-up, or carrying on other treatment during follow-up period
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02204358
Other Study ID Numbers  ICMJE 2012022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sponsor  ICMJE The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yali HU, MD,PhD Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
PRS Account The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP