In Vitro Follicle Activation in Patient With Premature Ovarian Failure Under 36 Years Old

Study Overview
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Brief Summary
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This is a clinical trial that the investigators aim to validate In-vitro Activation (IVA) treatment protocol, which was previously defined by Kazuhiro Kawamura (MD) and Aaron Hsueh (PhD), in Turkish patient with Premature Ovarian Insufficiency (POI) under age 36.

Detailed Description
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The objectives of the study is as following; Validation of the previously defined In-Vitro Activation Protocol approach in Turkish patients under 36 years old with Premature Ovarian Insufficiency (POI). Giving an opportunity to young POI patient in Turkey for having genetically own baby. Primary outcome measure would be live birth. For activation of primordial follicles, phosphatase and tensin homolog (PTEN) inhibitor and protein kinase B (AKT) stimulator will be used.

Official Title
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In Vitro Follicle Activation of Dormant Follicles in Patient With Premature Ovarian Failure Under 36 Years Old

Conditions
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Activation of Primordial Follicles

Intervention / Treatment
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* Procedure: In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with POI Short amenorrhea period (1 - 2 years) Exclusion Criteria: Having been treated with chemotherapy and/or radiotherapy; Having been diagnosed with advanced stage of endometriosis (endometriomas) Having been diagnosed with the chronic diseases such as diabetes, cardiac failure, kidney insufficiency, morbid obesity etc.. Presence of chromosomal abnormality (Turner, Fragile-X etc.) Previous multiple laparotomies Menopause >10 years Accompanied azoospermia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 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

| Intervention/Treatment |
| --- |
|Procedure: In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator|After laparoscopic unilateral oophorectomy, ovarian medulla would be dissected from cortex. After fragmentation of 2 cm square ovarian cortex into smaller pieces they would be incubated PTEN inhibitor and AKT stimulator for 48 hours. Finally we will auto graft these fragments beneath to the fallopian tube peritoneal surface.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth | The primary outcome is live birth, defined as the delivery of a live-born infant at 24 weeks of gestation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follicle growth rate | Number of ovulation induction cycle achieved to growth follicle | 1 year | 
| M-II oocyte rate | Number of mature oocyte rate among retrieved oocytes | 1 year | 
| Day 2-3 good quality embryo rate | Good quality embryo rate of fertilized oocytes (2PN) | 1 year | 
| Clinical pregnancy rate | A clinical pregnancy is a pregnancy that is confirmed by both high levels of human chorionic gonadotropin (hCG) and ultrasound confirmation of a gestational sac or heartbeat (fetal pole) | 2 years |