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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Premature Ovarian Failure Biological: Stem Cell Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure (POF)
Study Start Date : March 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 104 weeks ]
    Hormonal analysis


Secondary Outcome Measures :
  1. Menstruation [ Time Frame: 104 weeks ]
    Clinical


Other Outcome Measures:
  1. Ovulation [ Time Frame: 104 weeks ]
    Ultrasound


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151890


Locations
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Egypt
Al Azhar University
Cairo, Egypt
Sponsors and Collaborators
Al-Azhar University
Investigators
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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
More Information
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Responsible Party: Edessy Mahmoud, Professor, Al-Azhar University
ClinicalTrials.gov Identifier: NCT02151890     History of Changes
Other Study ID Numbers: Al Azhar University
POF women ( Registry Identifier: Al Azhar U )
Stem cell transplantation ( Registry Identifier: Al Azhar University )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Keywords provided by Edessy Mahmoud, Al-Azhar University:
POF
ESS
stem cell
Additional relevant MeSH terms:
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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases