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Completed

NCT Number: NCT02457481

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertility Laboratories of Colorado, Lone Tree, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Embryo Culture medium

Device

Two step sequential embryo culture medium system

Primary outcomes

  1. embryo development

    Time frame: 7 days after egg retrieval

    Blastocyst development and quality on days 5 and 6 of culture

  2. pregnancy rate

    Time frame: 2 months after egg retrieval

    The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.

  3. offspring weight

    Time frame: 1 year after egg retrieval

    The birth weight of children born

  4. offspring gender

    Time frame: 1 year after egg retrieval

    The gender of children born

Secondary outcomes

  1. fertilization

    Time frame: 2 days after egg retrieval

    the percentage of mature eggs that successfully fertilized normally

  2. euploid embryos

    Time frame: 1 month after egg retrieval

    For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts

Sponsors and collaborators

Lead sponsor

National Foundation for Fertility Research

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 29, 2015
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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