Completed

NCT Number: NCT04131244

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

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.

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Key information

Conditions

Activation of Primordial Follicles

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University School of Medicine, Department of Ob/Gyn

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

Other names: Laparoscopic unilateral oophorectomy, Laparoscopic auto grafting of ovarian cortex fragments sub-peritoneally

Primary outcomes

Live birth

Time frame: 2 years

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

Secondary outcomes

Follicle growth rate

Time frame: 1 year

Number of ovulation induction cycle achieved to growth follicle
M-II oocyte rate

Time frame: 1 year

Number of mature oocyte rate among retrieved oocytes
Day 2-3 good quality embryo rate

Time frame: 1 year

Good quality embryo rate of fertilized oocytes (2PN)
Clinical pregnancy rate

Time frame: 2 years

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)

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

St. Marianna University School of Medicine
Stanford University

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Oct 18, 2019
Registry last updated: Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.