Activation of Primordial FolliclesNCT04131244

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

A study testing In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator in people with Activation of Primordial Follicles, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 36 years, women only
Conditions the study is for: Activation of Primordial Follicles
What is being tested?: In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator
Type of treatment: Surgery or procedure
How many people: 10 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Dec 2017to 15 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 36 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Conditions: Activation of Primordial Follicles
Being tested: In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulatorProcedure or surgery
Also called Laparoscopic unilateral oophorectomy, Laparoscopic auto grafting of ovarian cortex fragments sub-peritoneally
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201715 Dec 2019

First posted18 Oct 2019
Study start1 Dec 2017
Primary completion15 Oct 2019
Study completion15 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Activation of Primordial FolliclesStudies of the same condition, open and under way.
More trials run by Hacettepe UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04131244
Sponsor's protocol ID: HU0616
Status last verified: Feb 2020
First submitted: 13 Jan 2018
Last updated: 12 Feb 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vitro Follicle Activation of Dormant Follicles in Patient With Premature Ovarian Failure Under 36 Years Old
ClinicalTrials.gov ID: NCT04131244
Acronym / sponsor ID: HU0616
Conditions: Activation of Primordial Follicles
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Hacettepe UniversityUniversity, hospital or other
Collaborators: St. Marianna University School of Medicine, Stanford University
Study start: 1 Dec 2017 (actual)
Primary completion: 15 Oct 2019 (actual)
Study completion: 15 Dec 2019 (actual)
First posted: 18 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 to 36 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulatorAlso: Laparoscopic unilateral oophorectomy, Laparoscopic auto grafting of ovarian cortex fragments sub-peritoneallyAfter 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.	Procedure or surgery	–

Primary outcome

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

4 secondary outcomes

Follicle growth rate
Time frame: 1 year
M-II oocyte rate
Time frame: 1 year
Day 2-3 good quality embryo rate
Time frame: 1 year
Clinical pregnancy rate
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04131244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.