Comparison of Culture Media for in Vitro Embryo Development

Study Overview
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Brief Summary
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The purpose of this study is to collect development and outcome data on human embryos which are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective to demonstrate its performance efficacy in comparison to existing commercially available single culture or continuous embryo culture media.

Detailed Description
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A multi-center (3 sites and 2 investigators), prospective trial with up to 300 patients. Patients will be enrolled from participating sites from the United States. Study sites will conduct this study under the oversight of Sterling IRB. Each study site should enroll enough patients to achieve at least 50 evaluable patients that have undergone a treatment cycle using split case sibling embryos in which half of the embryos are cultured in CSCM2 and the other half in current CSCM (as control). The methods will consist of standard ovarian stimulation protocols at each facility to obtain a sufficient number of mature (MII) oocytes for fertilization by ICSI. Following fertilization, identified diploid (2PN) zygotes will be evenly divided and randomly allocated to the embryo culture treatment conditions of CSCM2 or CSCM and cultured according to standard laboratory procedure (incubated in 5-6% CO2 in air or low O2 concentrations of 5-6%) to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen cycle. The procedures in this study are designed to follow the standard medical care at each study site for women having IVF treatment (the participant will sign a separate consent at your clinic for your IVF procedures). The participants study doctor will explain in detail the procedures participants will undergo at the clinic; this form is only meant to explain the details of the research study. This study does not involve randomization of patient participation or any sham procedures.

Official Title
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Prospective Observational Study Utilizing Next Generation Continuous Single Culture Media (CSCM2) for Comparative in Vitro Embryo Development and Outcome Data

Conditions
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Infertility

Intervention / Treatment
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* Other: CSCM2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age in good general physical and mental health. Women undergoing fresh in vitro fertilization treatment using their own eggs which will be fertilized by ICSI only Normal uterine cavity, as defined by the program. Normal BMI (< 35). Normal endocrine workup (including PCOS patients). Fresh or Frozen Blastocyst transfer At least 4 diploid zygotes showing signs of normal (2PN) fertilisation Willing to have half of their 2PN embryos cultured in CSCM and the other half of their 2PN embryos cultured in CSCM 2nd generation Willing to comply with study protocol and procedures Willing to provide written informed consent Exclusion Criteria: Use of donor egg / gestational carrier Couples for whom the male partner requires surgically extracted sperm (testicular or epididymal retrieval) History of complications related to tolerance to OCP's, Gonadotropins, Progesterone or estrogen. A medical condition that is contraindicated to pregnancy or gonadotropin therapy (eg. allergies, immune deficiency, etc.) History of cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CSCM Control<br>Control medium | |
| Experimental: CSCM2<br>New Formulation medium | Other: CSCM2<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Success | Live Birth | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation | Presence of Gestational Sac | 2 years | 
| Embryo Development | Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts) | 2 years |