Infertility, Reproductive Techniques, Assisted
Conditions
Keywords
Embryo Culture Techniques, Embryonic Development
Brief summary
The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.
Detailed description
Egg retrieval will be performed as per standard operating procedures. Eggs from a single patient are mixed together in a single group during the normal recovery and washing procedure following egg retrieval. The single group of eggs will be divided in half, then the embryologist will randomly place each half into one of the two culture media treatments, commercial or experimental. All mature eggs collected at retrieval will undergo fertilization per standard operating procedures according to physician recommendations. After fertilization (day 0), standard procedures involve in vitro embryo culture in a sequential two step media system. After confirmation of fertilization success on day 1, embryos are cultured until day 3 in step 1 medium (both commercial and experimental media are two step sequential culture systems). On day 3, embryos are evaluated and moved from step one to step two culture medium. On day 5 and day 6, embryo development will be assessed. Good quality blastocysts will either be transferred fresh or cryopreserved for later transfer and/or genetic testing.
Interventions
DEVICEEmbryo Culture medium
Two step sequential embryo culture medium system
Sponsors
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women of any age who come to Colorado Center for Reproductive Medicine for fertility treatment using IVF. * Patients can be of any race, culture, sexual orientation or ethnicity.
Exclusion criteria
* Minors are excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| offspring gender | 1 year after egg retrieval | The gender of children born |
| offspring weight | 1 year after egg retrieval | The birth weight of children born |
| embryo development | 7 days after egg retrieval | Blastocyst development and quality on days 5 and 6 of culture |
| pregnancy rate | 2 months after egg retrieval | The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fertilization | 2 days after egg retrieval | the percentage of mature eggs that successfully fertilized normally |
| euploid embryos | 1 month after egg retrieval | For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts |
Countries
United States
Outcome results
None listed