Clinical Trial: Bone Marrow Stem Cell Treatment for Asherman's Syndrome and Endometrial Atrophy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: New Therapeutic Approaches to Treat Asherman's Syndrome and Endometrial Atrophy Based in BM Stem Cells Autologous Transplantation

Brief Summary: The purpose of this study is to determine whether Bone Marrow Stem Cell transplantation may improve Assisted Reproduction Techniques (ART) outcomes in refractive Asherman's Syndrome or Atrophic Endometrium.

Detailed Summary:

This novel technique refers to the use of CD133+ autologous bone marrow stem-cells to regenerate the endometrium in patients with Asherman's Syndrome, Endometrial Atrophy or any condition that produce a destruction of the endometrium or its de novo creation in a bioengineered uterus.

It requires a previous mobilization in the peripheral blood of CD133+ autologous bone marrow stem cells, subsequent apheresis and transplant of the same cells in the spiral arterioles of the uterus with the aim to regenerate de novo the endometrium. This technique represents a new therapeutical approach for the treatment of endometrial regeneration problems such Asherman Syndrome and the endometrial atrophy since currently no specific treatment for these endometrial pathologies exist.

A prospective experimental non controlled study has been designed in order to assess the effectiveness of these technique as a new tool for treat Asherman's Syndrome and Endometrial Atrophy.


Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Current Primary Outcome:

  • Live-birth rate [ Time Frame: 15 months ]
    Live birth rate is the percentage of all cycles that lead to live birth, and is the pregnancy rate adjusted for miscarriages and stillbirths.
  • Ongoing pregnancy rate [ Time Frame: 9 months ]
    Ongoing pregnancy rate is the percentage of all cycles that lead to presence of heartbeat in Ultrasound scan at the end of the first trimester
  • Implantation Rate [ Time Frame: 6 months ]
    Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Endometrial thickness prior to the treatment [ Time Frame: 0 ]
    Endometrial thickness measured with Ultrasound in a previous treatment with Hormonal Replacement Therapy
  • Endometrial Thickness after treatment [ Time Frame: 3-6 months ]
    Endometrial thickness measured with Ultrasound with Hormonal Replacement Therapy 3-6 months after Bone Marrow Stem Cell Transplantation


Original Secondary Outcome: Same as current

Information By: Instituto Valenciano de Infertilidad, IVI VALENCIA

Dates:
Date Received: May 19, 2014
Date Started: April 2013
Date Completion:
Last Updated: April 21, 2015
Last Verified: April 2015