Infertility, Primary Ovarian Insufficiency
Conditions
Keywords
Reproductive Techniques, Assisted, Ovarian Follicle
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREIn Vitro Follicle Activation (IVA)
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.
DRUGFollicle Activation
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.
Sponsors
Fertility Laboratories Of Colorado
National Foundation for Fertility Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women diagnosed with primary ovarian insufficiency (POI), seeking pregnancy and eligible for IVF at Colorado Center for Reproductive Medicine (Lone Tree, CO). * Patients can be of any race, culture, sexual orientation or ethnicity.
Exclusion criteria
* Minors are excluded from participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antral follicle development measured by ultrasound examination | 1 year after auto-grafting | Ultrasound analysis of the number of follicles developing in the grafted ovarian tissue following activation in vitro |
| Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration | 1 year after auto-grafting | The number of oocytes recovered from follicles developing in the grafted ovarian tissue following in vitro activation |
| Pregnancy | 1.5 years after auto-grafting | The incidence of implantation and pregnancy following transfer of embryos produced from oocytes recovered from follicles developing in the activated ovarian tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Offspring weight | 1 year after egg retrieval | The birth weight of children born |
| Offspring gender | 1 year after egg retrieval | The gender of children born |
| Development of good quality blastocysts using the Gardner morphological blastocyst grading system | 1 week after egg retrieval | The proportion of good quality blastocyst stage embryos developed during in vitro fertilization (IVF) cycle(s), of the total number of fertilized eggs |
Countries
United States
Outcome results
None listed