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

Hacettepe University10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Activation of Primordial Follicles

Interventions

In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulatorPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 36 Years

Medical Language ↔ Plain English

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

Locations (1)

Hacettepe University School of Medicine, Department of Ob/Gyn

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Live birth

The primary outcome is live birth, defined as the delivery of a live-born infant at 24 weeks of gestation

Time frame: 2 years

Secondary Outcomes

Follicle growth rate

Number of ovulation induction cycle achieved to growth follicle

Time frame: 1 year

M-II oocyte rate

Number of mature oocyte rate among retrieved oocytes

Time frame: 1 year

Day 2-3 good quality embryo rate

Good quality embryo rate of fertilized oocytes (2PN)

Time frame: 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)

Time frame: 2 years

Data from ClinicalTrials.gov

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