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.

Study Overview

• Status: Completed
• Conditions: Infertility; Reproductive Techniques, Assisted
• Intervention / Treatment: Device: Embryo Culture medium

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Fertility Laboratories of Colorado
    • Lone Tree, Colorado, United States, 80124
      • National Fooundation for Fertility Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Embryo Culture medium; Two step sequential embryo culture medium system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Foundation for Fertility Research
• Investigators: Principal Investigator: Rebecca L Krisher, PhD, NFFR

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Embryo Culture Techniques; Embryonic Development
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: NFFR-OEC-2015