Clinical Trial: Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multi-center, Randomized, Single-blind, Controlled Clinical Trial of Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononu

Brief Summary: This study evaluates the addition of collagen scaffold loaded with autologous bone marrow mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the treatment of severe asherman syndrome. Half of participants will receive collagen/ABMNC scaffold after hysteroscopic adhesiolysis, while the other half will receive Foley catheter balloon.

Detailed Summary: Severe asherman syndrome will lead to infertility, and the most common method to treat asherman syndrome is operating to dissect adhesions. In order to prevent the postoperative re-adhesion, many physical isolation measures have been tried. However, they don't improve the microenvironment of endometrial regeneration. It's reported that bone marrow mononuclear cells have good effects on the functional recovery of injured uterus. This study will determine whether collagen scaffolds loaded with autologous bone marrow mononuclear cells will be more effective than Foley balloon catheters at treating infertile women with severe intrauterine adhesions who have taken hysteroscopic adhesiolysis. In addition, the study will be carried out in 2 centers, one is the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, the other is Changzhou Maternal and Child Health Care Hospital that is in Jiangsu Province.
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Current Primary Outcome: Persistent pregnancy rate [ Time Frame: up to 24 months ]

A successful clinical pregnancy means that at the 12th week of pregnancy, ultrasound reveals that the fetus had a heart activity and the size of the fetus is in consistent with the gestational week.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Menstrual blood volume [ Time Frame: at 3 and 6 months ]
    Understanding the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days, which will be compared with pre-operation.
  • Endometrial thickness [ Time Frame: at 1, 3 and 6 months ]
    Measure the endometrial thickness during ovulation by ultrasound by the same trained medical sonographers at 1, 3 and 6 months after surgery, comparing with pre-operation.
  • Endometrial blood supply [ Time Frame: at 1, 3 and 6 months ]
    Measure the endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers at 1, 3 and 6 months after surgery, comparing with pre-operation.
  • Reduction of intrauterine scar area [ Time Frame: up to 3 month ]
    Evaluating the reduction of scar and its area by hysteroscopy compared with pre-operation.
  • Miscarriage rate [ Time Frame: up to 24 months ]
  • placenta adhesion rate [ Time Frame: up to 24 months ]
  • live- birth rate [ Time Frame: up to 24 months ]


Original Secondary Outcome: Same as current

Information By: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Dates:
Date Received: January 30, 2016
Date Started: February 2016
Date Completion: December 2019
Last Updated: March 24, 2016
Last Verified: March 2016