Sequential vs. Monophasic Media Impact Trial (SuMMIT)

Study Overview
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Brief Summary
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To evaluate the impact of two FDA approved culture media on potential of human embryos resulting from IVF (sequential & monophasic media). Half of each patient's embryos will be randomly assigned to grow in monophasic media & the other half in sequential media. All embryos will undergo Comprehensive Chromosome Screening (CCS) & the best euploid embryo from each group will be transferred resulting in a double embryo transfer (DET). If there are only euploid embryos from one group, patient will have single embryo transfer (SET)(fresh or frozen).

Official Title
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Evaluation of the Impact of Monophasic vs. Sequential Media on the Reproductive Potential of Embryos Undergoing in Vitro Fertilization (IVF)

Conditions
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Infertility

Intervention / Treatment
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* Other: Comprehensive Chromosome Screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing IVF/CCS (no PGD banking) Patient meets ASRM guidelines for Double Embryo Transfer (DET) Donor Sperm OK AMH ≥ 1.2 FSH ≤ 12 BAFC ≥12 Max 1 prior failed IVF cycle for patients 35-45 years old Patient <35 years old MUST have 1 prior failed IVF cycle Exclusion Criteria: Chronic endometrial insufficiency Use of oocyte donor or gestational carriers Medical contraindications to Double Embryo Transfer (DET) Male Factor (<100,000 sperm or surgical sperm) Communicating hydrosalpinx (on HSG) Single gene disorders or sex selection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monophasic Media<br>Half of each patient's embryos will be randomly assigned to grow in monophasic media & the other half in sequential media. All embryos will undergo CCS & the best euploid embryo from each group will be transferred (DET). If there are only euploid embryos from one group, pt will have SET only (fresh or frozen) | Other: Comprehensive Chromosome Screening<br>* On day 5 or 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS) results will be available by the morning of day 6 if embryos are suitable for a fresh transfer which is the routine in our program.<br>|
| Placebo Comparator: Sequential Media<br>Half of each patient's embryos will be randomly assigned to grow in monophasic media & the other half in sequential media. All embryos will undergo CCS & the best euploid embryo from each group will be transferred (DET). If there are only euploid embryos from one group, pt will have SET only (fresh or frozen) | Other: Comprehensive Chromosome Screening<br>* On day 5 or 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS) results will be available by the morning of day 6 if embryos are suitable for a fresh transfer which is the routine in our program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates | To assess if pregnancy rates are impacted by the type of culture media embryos produced by IVF are cultured in | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monophasic, Sequential, Media