An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro

National Foundation for Fertility Research

Status: Completed

Conditions: Reproductive Techniques, Assisted; Infertility

Treatments: Device: Embryo Culture medium

Study type: Interventional

Funder types: Other

Identifiers

NCT02457481

NFFR-OEC-2015

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Embryo Culture medium

Experimental group

Description:

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).

Treatment:

Device: Embryo Culture medium