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

February 11, 2020 updated by: Sezcan Mumusoglu, Hacettepe University

In Vitro Follicle Activation of Dormant Follicles 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University School of Medicine, Department of Ob/Gyn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 36 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follicle growth rate
Time Frame: 1 year
Number of ovulation induction cycle achieved to growth follicle
1 year
M-II oocyte rate
Time Frame: 1 year
Number of mature oocyte rate among retrieved oocytes
1 year
Day 2-3 good quality embryo rate
Time Frame: 1 year
Good quality embryo rate of fertilized oocytes (2PN)
1 year
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)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Stanford University
St. Marianna University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

October 15, 2019

Study Completion (ACTUAL)

December 15, 2019

Study Registration Dates

First Submitted

January 13, 2018

First Submitted That Met QC Criteria

October 16, 2019

First Posted (ACTUAL)

October 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU0616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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