Infertility, Reproductive Techniques, Assisted
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEIVM media
Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture.
Low dose FSH is administered to stimulate follicle growth.
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
21 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Infertile women who desire to conceive and come to CCRM for infertility treatment using IVF will be candidates for this study. * Women with PCOS * Patients can be of any race, culture, sexual orientation or ethnicity.
Exclusion criteria
* Minors are excluded from participation in this study. * Women with a BMI greater than 40 * Women whose health is such that becoming pregnant carries risk significantly greater than healthy women are excluded from this study, unless they use a gestational carrier under the direction of their physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 6 months after egg retrieval | The incidence of pregnancy following embryo transfer of IVM produced embryos. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of good quality blastocysts using the Gardner morphological blastocyst grading system | 7 days after egg retrieval | The proportion of good quality blastocyst stage embryos developed from IVM eggs during in vitro fertilization (IVF), of the total number of oocytes recovered |
| Offspring Weight | 1 year after egg retrieval | The birth weight of children born following IVM |
| Offspring Gender | 1 year after egg retrieval | The gender of children born after IVM |
| Fertilization of eggs | 2 days after egg retrieval | The percentage of mature eggs that are successfully fertilized following IVM and IVF |
| Euploid Embryos | 1 month after egg retrieval | The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested |
Countries
United States
Contacts
Primary ContactRachel Makloski, RN
Backup ContactRebecca L Krisher, PhD
Outcome results
None listed