Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Ovarian Failure

Intervention / Treatment
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* Biological: Stem Cell


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Stem Cell Transplantation.<br>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<br>* 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).<br>* Other names: - Ultrasonic evaluation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Hormonal analysis | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstruation | Clinical | 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POF, ESS, stem cell