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

May 30, 2014 updated by: Edessy Mahmoud, Al-Azhar University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Al Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy
Time Frame: 104 weeks
Hormonal analysis
104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstruation
Time Frame: 104 weeks
Clinical
104 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation
Time Frame: 104 weeks
Ultrasound
104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Al Azhar University
  • POF women (Registry Identifier: Al Azhar U)
  • Stem cell transplantation (Registry Identifier: Al Azhar University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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