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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

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

Condition or disease Intervention/treatment Phase
Infertility Intrauterine Adhesions Endometrial Dysplasia Procedure: autologous bone marrow stem cells Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the Treatment of Infertility Caused by Severe Intrauterine Adhesions by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells
Study Start Date : January 2012
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: autologous bone marrow stem cells
Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. rate of pregnancy [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02204358


Contacts
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Contact: Yali Hu, MD PhD 02583304616 ext 66808 819241652@qq.com

Locations
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China, Jiangsu
Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Yali HU , MD,PhD    02583304616 ext 66808    dtylhu@126.com   
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 Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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Responsible Party: Yali Hu, MD,PhD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT02204358     History of Changes
Other Study ID Numbers: 2012022
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Infertility
Tissue Adhesions
Genital Diseases, Male
Genital Diseases, Female
Cicatrix
Fibrosis
Pathologic Processes