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

Primary Purpose

Activation of Primordial Follicles

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator
Sponsored by
Hacettepe University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Activation of Primordial Follicles

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University School of Medicine, Department of Ob/Gyn

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2018
Last Updated
February 11, 2020
Sponsor
Hacettepe University
Collaborators
St. Marianna University School of Medicine, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04131244
Brief Title
In Vitro Follicle Activation in Patient With Premature Ovarian Failure Under 36 Years Old
Official Title
In Vitro Follicle Activation of Dormant Follicles in Patient With Premature Ovarian Failure Under 36 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
St. Marianna University School of Medicine, Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Activation of Primordial Follicles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator
Other Intervention Name(s)
Laparoscopic unilateral oophorectomy, Laparoscopic auto grafting of ovarian cortex fragments sub-peritoneally
Intervention Description
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.
Primary Outcome Measure Information:
Title
Live birth
Description
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 Outcome Measure Information:
Title
Follicle growth rate
Description
Number of ovulation induction cycle achieved to growth follicle
Time Frame
1 year
Title
M-II oocyte rate
Description
Number of mature oocyte rate among retrieved oocytes
Time Frame
1 year
Title
Day 2-3 good quality embryo rate
Description
Good quality embryo rate of fertilized oocytes (2PN)
Time Frame
1 year
Title
Clinical pregnancy rate
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hacettepe University School of Medicine, Department of Ob/Gyn
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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