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

Not Applicable

Completed

• Conditions: Activation of Primordial Follicles

• Registration Number: NCT04131244
• Lead Sponsor: Hacettepe University

Brief Summary

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

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 Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-01-13
• Primary Completion: 2019-10-15
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Completion: 2019-12-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Live birth	2 years	The primary outcome is live birth, defined as the delivery of a live-born infant at 24 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Follicle growth rate	1 year	Number of ovulation induction cycle achieved to growth follicle
M-II oocyte rate	1 year	Number of mature oocyte rate among retrieved oocytes
Day 2-3 good quality embryo rate	1 year	Good quality embryo rate of fertilized oocytes (2PN)
Clinical pregnancy rate	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)

Trial Locations

Locations (1)

Hacettepe University School of Medicine, Department of Ob/Gyn; 🇹🇷 Ankara, Turkey