Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure

Phase 1

Completed

• Conditions: Premature Ovarian Failure
• Interventions: Biological: Stem Cell

• Registration Number: NCT02151890
• Lead Sponsor: Al-Azhar University

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 Timeline

• Study Start: 2012-03
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-30
• Last Update Submitted: 2014-05-30
• Study First Posted: 2014-06-02
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic Stem Cell Transplantation.	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 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.

Primary Outcome Measures

Name	Time	Method
Pregnancy	104 weeks	Hormonal analysis

Secondary Outcome Measures

Name	Time	Method
Menstruation	104 weeks	Clinical

Trial Locations

Locations (1)

Al Azhar University; 🇪🇬 Cairo, Egypt