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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02457481
Other study ID # NFFR-OEC-2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date August 2018

Study information

Verified date August 2018
Source National Foundation for Fertility Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Embryo Culture medium
Two step sequential embryo culture medium system

Locations

Country Name City State
United States Fertility Laboratories of Colorado Lone Tree Colorado
United States National Fooundation for Fertility Research Lone Tree Colorado

Sponsors (1)

Lead Sponsor Collaborator
National Foundation for Fertility Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary embryo development Blastocyst development and quality on days 5 and 6 of culture 7 days after egg retrieval
Primary pregnancy rate The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination. 2 months after egg retrieval
Primary offspring weight The birth weight of children born 1 year after egg retrieval
Primary offspring gender The gender of children born 1 year after egg retrieval
Secondary fertilization the percentage of mature eggs that successfully fertilized normally 2 days after egg retrieval
Secondary euploid embryos For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts 1 month after egg retrieval
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