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
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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 |
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Premature Ovarian Failure | Biological: Stem Cell | Phase 1 Phase 2 |
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 (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 |

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.
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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:
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- Pregnancy [ Time Frame: 104 weeks ]Hormonal analysis
- Menstruation [ Time Frame: 104 weeks ]Clinical
- Ovulation [ Time Frame: 104 weeks ]Ultrasound

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
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.

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
Egypt | |
Al Azhar University | |
Cairo, Egypt |
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 |
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 |
POF ESS stem cell |
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 |