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Completed

NCT Number: NCT02144987

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinico y Universitario de Valencia, Valencia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed of Asherman Syndrome and absence of pregnancy after treatment
  • Endometrial atrophy (<6mm) with Implantation Failure
  • Age 20-45 years-old
  • Normal liver, heart and kidney function
  • Presence of menstrual bleeding with Natural Cycle or HRT
  • Absence of psychiatric pathology and ability to accomplish the treatment
  • β-hCG negative
  • Absence of SDT

Exclusion criteria

  • Absence of peripheral vein access
  • Lack of accomplish inclusion criteria

Treatment and study plan

Bone Marrow CD133+ Stem Cell Transplantation

Biological
  • Bone Marrow Stem Cell (BMSC) mobilization peripheral blood induced by granulocyte-CSF (G-CSF) 5 mcg/kg sc every 12 hours for 4 days.
  • BMSC recollection with apheresis procedure and positive selection of the CD133+ cells.

The selection procedure will be performed for a maximum of 3 hours or until at least 50 million cells are collected.

  • CD133+ cells transplantation into the uterine spiral arterioles by intra-arterial catheterization
  • Subsequently Hormonal Replacement Therapy (HRT) will be given to the patients
  • Hysteroscopy will be performed 2-3 months after stem cell transplantation
  • Embryo transfer will be performed 3-6 months after stem cell transplantation with HRT endometrial preparation

Other names: Neupogen

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. Endometrial thickness prior to the treatment

    Endometrial thickness measured with Ultrasound in a previous treatment with Hormonal Replacement Therapy

  2. 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

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

Registry information

Official study title

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

Acronym: BMSCT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 22, 2014
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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