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Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure (POF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02151890
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Edessy Mahmoud, Al-Azhar University

Tracking Information
First Submitted Date  ICMJE May 22, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date June 2, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
Pregnancy [ Time Frame: 104 weeks ]
Hormonal analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
Menstruation [ Time Frame: 104 weeks ]
Clinical
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 30, 2014)
Ovulation [ Time Frame: 104 weeks ]
Ultrasound
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure
Official Title  ICMJE Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure (POF)
Brief Summary

Out of 112 high risk patients for Premature Ovarian Failure (POF), diagnosis was established in 10 cases.

ESS cut off point for menstruation and pregnancy was 6.

Detailed Description

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 immubohistchemical (IH) staining by stem cell marker OCT4. IH expression of stem cell marker OCT4 was evaluated before and after transplantation according to Edessy Stem Cell Score (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), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).

These cases were of ESS 5 and 6.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Premature Ovarian Failure
Intervention  ICMJE 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).
Other Names:
  • - Edessy Stem cell Score.
  • - Laparoscopic stem cell transplantation.
  • - Hormonal Analysis
  • - Ultrasonic evaluation
Study Arms  ICMJE Experimental: Laparoscopic Stem Cell Transplantation.
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 IH staining by stem cell marker OCT4. Immunohistochemical expression of stem cell marker OCT4 was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS)Laparoscopic injected of stem cell Sample in the ovaries.. Participants were followed up monthly for a period of six months by hormonal (FSH, LH and E2), clinical (resuming menstruation), US (folliculometry), histopathological (HP), and IH expression of stem cell marker OCT4 of the endometrial biopsy (stem cell positivity according to ESS) outcome.
Intervention: Biological: Stem Cell
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2014)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Post-menarche female less than 40 years old.
  • Normal karyotyping female.
  • Primary ovarian failure females
  • Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
  • Agree to sign the designed consent for the study.

Exclusion Criteria:

  • Autoimmune diseases.
  • Breast cancer, ovarian cancer.
  • Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
  • Those with major medical problems such as malignancy, hepatitis, etc.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02151890
Other Study ID Numbers  ICMJE Al Azhar University
POF women ( Registry Identifier: Al Azhar U )
Stem cell transplantation ( Registry Identifier: Al Azhar University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edessy Mahmoud, Al-Azhar University
Study Sponsor  ICMJE Al-Azhar University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mahmoud Edessy, Professor Al-Azhar University
Study Chair: Hala N Hosni, Professor Cairo University
Study Chair: Yehia Wafa, Professor Al-Azhar University
Study Chair: Yousef Shady, MD Al-Azhar University
Study Chair: Sayed Bakri, MD Al-Azhar University
Study Chair: Medhat Kamel, Msc Al-Azhar University
PRS Account Al-Azhar University
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP