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

Activation of Primordial Follicles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131244
• Other study ID #: HU0616
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Activation of Primordial Follicles
• Menopause, Premature
• Primary Ovarian Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hacettepe University School of Medicine, Department of Ob/Gyn	Ankara

Sponsors (3)

Lead Sponsor	Collaborator
Hacettepe University	St. Marianna University School of Medicine, Stanford University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Follicle growth rate	Number of ovulation induction cycle achieved to growth follicle	1 year
Secondary	M-II oocyte rate	Number of mature oocyte rate among retrieved oocytes	1 year
Secondary	Day 2-3 good quality embryo rate	Good quality embryo rate of fertilized oocytes (2PN)	1 year
Secondary	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