The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI).
The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI; also known as premature ovarian failure). Patients diagnosed with POI are infertile due to a lack of follicle growth and ovulation; oocyte donation is the only treatment option currently available to enable these women to have a child. IVA treatment may result in the rescue of the remaining primordial follicles within the ovary, thus making oocytes available for IVF, embryo production, transfer and pregnancy. In this experimental treatment, ovarian tissue is removed from the patient and cultured in vitro for 48 hours with specific compounds to activate dormant primordial follicles. Following activation ovarian tissue is auto-grafted to the serosa of the fallopian tube, and the patient is monitored for signs of follicle growth. Growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and IVF.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Laparoscopic removal of ovarian tissue, followed by in vitro activation of dormant ovarian follicles and autografting back to the patient for follicle growth and egg retrieval.
Ovarian cortical pieces will be treated in vitro with a PTEN activator (bpV(hopic)) and a PI3K inhibitor (740YP) in vitro to activate primordial ovarian follicles, prior to autografting.
Fertility Laboratories of Colorado
Lone Tree, Colorado, United States
National Foundation for Fertility Research
Lone Tree, Colorado, United States
Antral follicle development measured by ultrasound examination
Ultrasound analysis of the number of follicles developing in the grafted ovarian tissue following activation in vitro
Time frame: 1 year after auto-grafting
Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration
The number of oocytes recovered from follicles developing in the grafted ovarian tissue following in vitro activation
Time frame: 1 year after auto-grafting
Pregnancy
The incidence of implantation and pregnancy following transfer of embryos produced from oocytes recovered from follicles developing in the activated ovarian tissue.
Time frame: 1.5 years after auto-grafting
Offspring weight
The birth weight of children born
Time frame: 1 year after egg retrieval
Offspring gender
The gender of children born
Time frame: 1 year after egg retrieval
Development of good quality blastocysts using the Gardner morphological blastocyst grading system
The proportion of good quality blastocyst stage embryos developed during in vitro fertilization (IVF) cycle(s), of the total number of fertilized eggs
Time frame: 1 week after egg retrieval
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.