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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457481
• Other study ID #: NFFR-OEC-2015
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• Reproductive Techniques, Assisted

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