New Therapeutic Approaches to Treat Asherman's Syndrome and Endometrial Atrophy Based in BM Stem Cells Autologous Transplantation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Implantation Rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
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
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.
Secondary Outcomes
- Endometrial thickness prior to the treatment(0)
- Endometrial Thickness after treatment(3-6 months)