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

Al-Azhar University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Premature Ovarian Failure

Treatments: Biological: Stem Cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02151890

Stem cell transplantation (Registry Identifier)

Al Azhar University

POF women (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Laparoscopic Stem Cell Transplantation.

Experimental group

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 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.

Treatment:

Biological: Stem Cell