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

Phase 4

Completed

• Conditions: Asherman's Syndrome; Endometrium; Atrophy, Cervix

• Registration Number: NCT02144987
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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 Description

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-22
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Implantation Rate	6 months	Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.
Ongoing pregnancy rate	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
Live-birth rate	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hospital Clinico y Universitario de Valencia; 🇪🇸 Valencia, Spain

Instituto Valenciano Infertilidad; 🇪🇸 Valencia, Spain