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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Infertility Reproductive Techniques, Assisted

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Embryo Culture medium

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).

Group Type EXPERIMENTAL

Embryo Culture medium

Intervention Type DEVICE

Two step sequential embryo culture medium system

Interventions

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Embryo Culture medium

Two step sequential embryo culture medium system

Intervention Type DEVICE

Eligibility Criteria

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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.