Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure
|ClinicalTrials.gov Identifier: NCT02043743|
Recruitment Status : Unknown
Verified January 2014 by El-Rayadh Fertility Centre.
Recruitment status was: Recruiting
First Posted : January 23, 2014
Last Update Posted : January 23, 2014
Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary ovarian insufficiency (this is the most accurate term as some women may still conceive), premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to function adequately in a woman younger than 40 years, in its role either as an endocrine organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism, and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer responding to circulating FSH by producing estrogen and developing fertile eggs) in women younger than 40 years. This condition occurs in approximately 1% of women and it has important physical and psychological consequences/impact in those patients.
The purpose of this study is to investigate the role of the transplantation of bone marrow derived stem cells into ovarian tissue for treatment of premature ovarian failure and to assess their ability to differentiate into germ cells.
|Condition or disease||Intervention/treatment||Phase|
|Premature Ovarian Failure||Biological: Biological: Stem Cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||January 2015|
Experimental: Laboratory and Clinical
Biological: Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
Stem Cell Dose:
•3-5 Million Autologous MSCs Injected into Ovarian tissue.
Biological: Biological: Stem Cells
Biological: Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally 3-5 million MSCs injected into ovarian tissue.
Other Name: Stem Cells Transplantation
- Cases Improvement [ Time Frame: 48 Weeks ]Decline in serum FSH level. Rise in serum estrogen level Elevation in serum AMH level
- Cases Improvement [ Time Frame: 48 Weeks ]Disappearance of menopausal symptoms e.g. hot flashes Rise in serum AMH level. Pregnancy rate within 1 year. Miscarriage rate within one year of injection. Long term follow-up for any adverse effect, assessed for one year from injection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043743
|Contact: Hesham Elshaer, MDfirstname.lastname@example.org|
|El-Rayadh Fertility Center||Recruiting|
|Contact: Hesham Elshaer, MD +201223130881 email@example.com|
|Principal Investigator:||Prof.Dr. Hesham Elshaer, MD||El-Rayadh Fertility Center|
|Study Director:||Sayed Bakry, PhD||Al-Azhar University|
|Study Chair:||Wael Abu El Khier, MD||Military Academy|
|Study Chair:||Hala Gabr, MD||Cairo University|