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

Study Overview
=================
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.

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

Conditions
-----------------
Infertility, Reproductive Techniques, Assisted

Intervention / Treatment
-----------------
* Device: Embryo Culture medium


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embryo Culture medium<br>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<br>* Two step sequential embryo culture medium system<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embryo Culture Techniques, Embryonic Development