This trial is active, not recruiting.

Conditions infertility, reproductive techniques, assisted
Treatment embryo culture medium
Sponsor National Foundation for Fertility Research
Start date May 2015
End date August 2016
Trial size 100 participants
Trial identifier NCT02457481, NFFR-OEC-2015


The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Embryos from each patient are randomly allocated to culture in the commercial or experimental embryo culture medium (half of the embryos in commercial and half in experimental medium).
embryo culture medium
Two step sequential embryo culture medium system

Primary Outcomes

embryo development
time frame: 7 days after egg retrieval
pregnancy rate
time frame: 2 months after egg retrieval
offspring weight
time frame: 1 year after egg retrieval
offspring gender
time frame: 1 year after egg retrieval

Secondary Outcomes

time frame: 2 days after egg retrieval
euploid embryos
time frame: 1 month after egg retrieval

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro
Principal investigator Rebecca L Krisher, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by National Foundation for Fertility Research.