Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure

Premature Ovarian Failure Clinical Trial

— POF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151890
• Other study ID #: Al Azhar University
• Secondary ID: POF womenStem ce
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 22, 2014
• Last updated: May 30, 2014
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

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).

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ovulation	Ultrasound	104 weeks	Yes
Primary	Pregnancy	Hormonal analysis	104 weeks	Yes
Secondary	Menstruation	Clinical	104 weeks	Yes