Because a large proportion of the embryo's quality is dependent upon the egg, this investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In typical IVF cycles, the egg is recovered when it is mature and ready to be fertilized. However, at this point the oocyte's quality has been set, and cannot be altered. Therefore, to have an impact on oocyte quality the use of in IVM is critical. Development of a successful IVM protocol for clinical use would not only provide an option for women of advanced maternal age, it would also reduce the cost of IVF due to fewer exogenous gonadotropins used for stimulation, and significantly lessen the risk of ovarian hyper-stimulation. The objective of this research study is to evaluate a newly developed oocyte maturation media system for human clinical use in assisted reproductive technology (ART).
The novel device (IVM media system), is designed to support nuclear maturation of immature oocytes recovered after minimal ovarian stimulation with no LH/hCG administration, and improve oocyte competence. This may result in development of a greater number of embryos to the blastocyst stage. FSH is administered starting on cycle day 3 to stimulate follicle growth. When the leading follicle reaches 12-14 mm, egg retrieval will be scheduled. No hCG/LH trigger will be administered. Specially designed maturation media is used to collect and culture the immature eggs once recovered from the follicle. Once the eggs have matured in vitro, fertilization and embryo culture, vitrification and comprehensive chromosomal screening will be completed as per standard operating procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture.
Low dose FSH is administered to stimulate follicle growth.
Fertility Laboratories of Colorado
Lone Tree, Colorado, United States
RECRUITINGNational Foundation for Fertility Research
Lone Tree, Colorado, United States
RECRUITINGPregnancy
The incidence of pregnancy following embryo transfer of IVM produced embryos.
Time frame: 6 months after egg retrieval
Development of good quality blastocysts using the Gardner morphological blastocyst grading system
The proportion of good quality blastocyst stage embryos developed from IVM eggs during in vitro fertilization (IVF), of the total number of oocytes recovered
Time frame: 7 days after egg retrieval
Offspring Weight
The birth weight of children born following IVM
Time frame: 1 year after egg retrieval
Offspring Gender
The gender of children born after IVM
Time frame: 1 year after egg retrieval
Fertilization of eggs
The percentage of mature eggs that are successfully fertilized following IVM and IVF
Time frame: 2 days after egg retrieval
Euploid Embryos
The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested
Time frame: 1 month after egg retrieval
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