NCT04131244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

January 13, 2018

Last Update Submit

February 11, 2020

Conditions

Activation of Primordial Follicles

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Follicle growth rate

    1 year

  • M-II oocyte rate

    1 year

  • Day 2-3 good quality embryo rate

    1 year

  • Clinical pregnancy rate

    2 years

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.

Also known as: Laparoscopic unilateral oophorectomy, Laparoscopic auto grafting of ovarian cortex fragments sub-peritoneally

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with POI
  • Short amenorrhea period (1 - 2 years)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University School of Medicine, Department of Ob/Gyn

Ankara, 06100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2018

First Posted

October 18, 2019

Study Start

December 1, 2017

Primary Completion

October 15, 2019

Study Completion

December 15, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)