Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05703308
Status:
COMPLETED
Last Update Posted:
2023-01-30
First Post:
2023-01-15
Brief Title:
Menstrual Blood Stem Cells in Poor Ovarian Responders
Sponsor:
Avicenna Research Institute
Organization:
Avicenna Research Institute
Study Overview
Official Title:
Outcome of Pregnancy in Poor Ovarian Responders by Intraovarian Administration of Autologous Menstrual Blood Derived-Mesenchymal Stromal Cells
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this controlled trial poor ovarian responder women will be treated with transplantation of autologous menstrual blood stem cells The investigators will attempt to assess the safety and efficacy of this procedure for the treatment of infertility in POR patients compared to control group
Detailed Description:
With economic development procreation delays have resulted in more women seeking medical help for infertility treatment Because the quality and quantity of oocytes are affected by physiological age despite advances in assisted reproductive technology ART managing infertility in women with poor ovarian response POR remains a daily challenge for physicians
Adult mesenchymal stromal cell MSC therapy has gained particular interest in recent years because it may provide a supportive microenvironment for oocyte development from quiescent primordial follicles Human MSC transplantation has been shown in preclinical studies to host ovaries and restore their function and structure premature ovarian failure POF animal models
Because of their encouraging characteristics such as ease of access high availability monthly repeatability of sampling less ethical considerations lack of tumor-causing potential protected property and significant trans-differentiation capacity endometrial-derived stromal cells have been considered in a wide range of studies since 2007 Menstrual blood-derived stromal cells MenSCs on the other hand are derived from endometrial tissue and can be collected in a non-invasive manner making them especially useful in the treatment of reproductive disorders The investigators attempted to assess the safety and efficacy of intraovarian injection of MenSCs for the treatment of infertility in POR patients based on this evidence
The results of this clinical trials phases I and II indicated that Men-MSCs could be considered as a potential treatment to restore the fertility capability of POR women Based on these findings the investigators have designed a Phase III controlled trial of autologous MenSC therapy for patients with POR
Adult mesenchymal stromal cell MSC therapy has gained particular interest in recent years because it may provide a supportive microenvironment for oocyte development from quiescent primordial follicles Human MSC transplantation has been shown in preclinical studies to host ovaries and restore their function and structure premature ovarian failure POF animal models
Because of their encouraging characteristics such as ease of access high availability monthly repeatability of sampling less ethical considerations lack of tumor-causing potential protected property and significant trans-differentiation capacity endometrial-derived stromal cells have been considered in a wide range of studies since 2007 Menstrual blood-derived stromal cells MenSCs on the other hand are derived from endometrial tissue and can be collected in a non-invasive manner making them especially useful in the treatment of reproductive disorders The investigators attempted to assess the safety and efficacy of intraovarian injection of MenSCs for the treatment of infertility in POR patients based on this evidence
The results of this clinical trials phases I and II indicated that Men-MSCs could be considered as a potential treatment to restore the fertility capability of POR women Based on these findings the investigators have designed a Phase III controlled trial of autologous MenSC therapy for patients with POR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None