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

Not Applicable

Completed

• Conditions: Infertility; Reproductive Techniques, Assisted
• Interventions: Device: Embryo Culture medium

• Registration Number: NCT02457481
• Lead Sponsor: National Foundation for Fertility Research

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-05-29
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embryo Culture medium	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).

Primary Outcome Measures

Name	Time	Method
embryo development	7 days after egg retrieval	Blastocyst development and quality on days 5 and 6 of culture
pregnancy rate	2 months after egg retrieval	The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.
offspring gender	1 year after egg retrieval	The gender of children born
offspring weight	1 year after egg retrieval	The birth weight of children born

Secondary Outcome Measures

Name	Time	Method
fertilization	2 days after egg retrieval	the percentage of mature eggs that successfully fertilized normally
euploid embryos	1 month after egg retrieval	For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts

Trial Locations

Locations (2)

Fertility Laboratories of Colorado; 🇺🇸 Lone Tree, Colorado, United States

National Fooundation for Fertility Research; 🇺🇸 Lone Tree, Colorado, United States