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

Primary Purpose

Premature Ovarian Failure

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Stem Cell

About this trial

This is an interventional treatment trial for Premature Ovarian Failure focused on measuring POF, ESS, stem cell

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

Al Azhar University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laparoscopic Stem Cell Transplantation.

Arm 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.

Outcomes

Primary Outcome Measures

Pregnancy

Hormonal analysis

Secondary Outcome Measures

Menstruation

Clinical

Full Information

NCT ID

NCT02151890

First Posted

May 22, 2014

Last Updated

May 30, 2014

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT02151890

Brief Title

Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure

Acronym

POF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Ovarian Failure

Keywords

POF, ESS, stem cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic Stem Cell Transplantation.

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Stem Cell

Other Intervention Name(s)

- Edessy Stem cell Score., - Laparoscopic stem cell transplantation., - Hormonal Analysis, - Ultrasonic evaluation

Intervention 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 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).

Primary Outcome Measure Information:

Title

Pregnancy

Description

Hormonal analysis

Time Frame

104 weeks

Secondary Outcome Measure Information:

Title

Menstruation

Description

Clinical

Time Frame

104 weeks

Other Pre-specified Outcome Measures:

Title

Ovulation

Description

Ultrasound

Time Frame

104 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: