NCT02151890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

May 22, 2014

Last Update Submit

May 30, 2014

Conditions

Premature Ovarian Failure

Keywords

POFESSstem cell

Outcome Measures

Primary Outcomes (1)

  • Pregnancy

    Hormonal analysis

    104 weeks

Secondary Outcomes (1)

  • Menstruation

    104 weeks

Other Outcomes (1)

  • Ovulation

    104 weeks

Study Arms (1)

Laparoscopic Stem Cell Transplantation.

EXPERIMENTAL

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.

Biological: Stem Cell

Interventions

Stem CellBIOLOGICAL

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).

Also known as: - Edessy Stem cell Score., - Laparoscopic stem cell transplantation., - Hormonal Analysis, - Ultrasonic evaluation
Laparoscopic Stem Cell Transplantation.

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Autoimmune diseases.
  • Breast cancer, ovarian cancer.
  • Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
  • Those with major medical problems such as malignancy, hepatitis, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Mahmoud Edessy, Professor

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2014

First Posted

June 2, 2014

Study Start

March 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

EG(1)