Activation of Primordial Follicles
Conditions
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.
Interventions
PROCEDUREIn 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.
Sponsors
St. Marianna University School of Medicine
Stanford University
Hacettepe University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth | 2 years | The primary outcome is live birth, defined as the delivery of a live-born infant at 24 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follicle growth rate | 1 year | Number of ovulation induction cycle achieved to growth follicle |
| M-II oocyte rate | 1 year | Number of mature oocyte rate among retrieved oocytes |
| Day 2-3 good quality embryo rate | 1 year | Good quality embryo rate of fertilized oocytes (2PN) |
| Clinical pregnancy rate | 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) |
Countries
Turkey (Türkiye)
Outcome results
None listed