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POF: Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure

Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT02151890
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
26
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
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 :
Mar 1, 2012
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

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

    Primary Outcome Measures

    1. Pregnancy [104 weeks]

      Hormonal analysis

    Secondary Outcome Measures

    1. Menstruation [104 weeks]

      Clinical

    Other Outcome Measures

    1. Ovulation [104 weeks]

      Ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Al Azhar University Cairo Egypt

    Sponsors and Collaborators

    • Al-Azhar University

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edessy Mahmoud, Professor, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT02151890
    Other Study ID Numbers:
    • Al Azhar University
    • POF women
    • Stem cell transplantation
    First Posted:
    Jun 2, 2014
    Last Update Posted:
    Jun 2, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Edessy Mahmoud, Professor, Al-Azhar University
    POF
    ESS
    stem cell
    Additional relevant MeSH terms:
    Premature Birth
    Primary Ovarian Insufficiency
    Menopause, Premature

    Study Results

    No Results Posted as of Jun 2, 2014