An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro
Primary Purpose
Infertility, Reproductive Techniques, Assisted
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embryo Culture medium
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Embryo Culture Techniques, Embryonic Development
Eligibility Criteria
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
Sites / Locations
- Fertility Laboratories of Colorado
- National Fooundation for Fertility Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Embryo Culture medium
Arm Description
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).
Outcomes
Primary Outcome Measures
embryo development
Blastocyst development and quality on days 5 and 6 of culture
pregnancy rate
The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.
offspring weight
The birth weight of children born
offspring gender
The gender of children born
Secondary Outcome Measures
fertilization
the percentage of mature eggs that successfully fertilized normally
euploid embryos
For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts
Full Information
NCT ID
NCT02457481
First Posted
May 13, 2015
Last Updated
August 27, 2018
Sponsor
National Foundation for Fertility Research
1. Study Identification
Unique Protocol Identification Number
NCT02457481
Brief Title
An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro
Official Title
An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Foundation for Fertility Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Reproductive Techniques, Assisted
Keywords
Embryo Culture Techniques, Embryonic Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Embryo Culture medium
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Embryo Culture medium
Intervention Description
Two step sequential embryo culture medium system
Primary Outcome Measure Information:
Title
embryo development
Description
Blastocyst development and quality on days 5 and 6 of culture
Time Frame
7 days after egg retrieval
Title
pregnancy rate
Description
The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.
Time Frame
2 months after egg retrieval
Title
offspring weight
Description
The birth weight of children born
Time Frame
1 year after egg retrieval
Title
offspring gender
Description
The gender of children born
Time Frame
1 year after egg retrieval
Secondary Outcome Measure Information:
Title
fertilization
Description
the percentage of mature eggs that successfully fertilized normally
Time Frame
2 days after egg retrieval
Title
euploid embryos
Description
For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts
Time Frame
1 month after egg retrieval
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca L Krisher, PhD
Organizational Affiliation
NFFR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Laboratories of Colorado
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
National Fooundation for Fertility Research
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro
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