Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure (POF)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Pregnancy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- 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.
Arms & Interventions
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: Stem Cell (Biological)
Outcomes
Primary Outcomes
Pregnancy
Time Frame: 104 weeks
Hormonal analysis
Secondary Outcomes
- Menstruation(104 weeks)
Investigators
Edessy Mahmoud
Professor
Al-Azhar University