In Vitro Activation of Primordial Follicles as a Method to Treat Infertility Caused by Primary Ovarian Insufficiency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
In Vitro Follicle Activation (IVA)
Ovarian tissue will be removed and cultured in vitro with compounds to activate dormant follicles. Following activation, ovarian tissue will be auto-grafted and the patient monitored for follicular growth.
Intervention: In Vitro Follicle Activation (IVA) (Procedure)
In Vitro Follicle Activation (IVA)
Ovarian tissue will be removed and cultured in vitro with compounds to activate dormant follicles. Following activation, ovarian tissue will be auto-grafted and the patient monitored for follicular growth.
Intervention: Follicle Activation (Drug)
Outcomes
Primary Outcomes
Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration
Time Frame: 1 year after auto-grafting
The number of oocytes recovered from follicles developing in the grafted ovarian tissue following in vitro activation
Pregnancy
Time Frame: 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.
Antral follicle development measured by ultrasound examination
Time Frame: 1 year after auto-grafting
Ultrasound analysis of the number of follicles developing in the grafted ovarian tissue following activation in vitro
Secondary Outcomes
- Offspring gender(1 year after egg retrieval)
- Development of good quality blastocysts using the Gardner morphological blastocyst grading system(1 week after egg retrieval)
- Offspring weight(1 year after egg retrieval)