"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure
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|ClinicalTrials.gov Identifier: NCT02372474|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Premature Ovarian Failure||Biological: Stem cell||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Stem Cell therapy in POF
POF cases were evaluated hormonally, HP and IH using ESS. Autologous MSC were prepared and laparoscopically transplanted.
Biological: Stem cell
Out of 112 high risk patients for POF diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H&E stain and by Immunohistochemical (IH) staining by stem cell marker OCT4. IH expression of stem cell was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation and pregnancy), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).
- Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF. [ Time Frame: 128 weeks ]Cases underwent sc transplantation were followed up for occurrence of menstruation and pregnancy.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372474
|Al Azhar University|
|Principal Investigator:||Mahmoud Edessy, Professor||Al-Azhar University|
|Study Chair:||Hala N Hosni, Professor||Cairo University|
|Study Chair:||Yousef Shdy, MD||Al-Azhar University|
|Study Chair:||Syed Bkry, MD||Al-Azhar University|
|Study Chair:||Medhat Kamel, Msc||Al-Azhar University|