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

NCT ID: NCT04131244

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-12-15

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.

Conditions

Activation of Primordial Follicles

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Laparoscopic unilateral oophorectomy; Laparoscopic auto grafting of ovarian cortex fragments sub-peritoneally

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Marianna University School of Medicine

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Sezcan Mumusoglu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University School of Medicine, Department of Ob/Gyn

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HU0616

Identifier Type: -

Identifier Source: org_study_id