Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monophasic Media | Experimental | 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) |
|
| Sequential Media | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Chromosome Screening | Other | 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard T. Scott, M.D., HCLD | Reproductive Medicine Associates of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Associates of New Jersey | Basking Ridge | New Jersey | 07920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26826274 | Derived | Werner MD, Hong KH, Franasiak JM, Forman EJ, Reda CV, Molinaro TA, Upham KM, Scott RT Jr. Sequential versus Monophasic Media Impact Trial (SuMMIT): a paired randomized controlled trial comparing a sequential media system to a monophasic medium. Fertil Steril. 2016 May;105(5):1215-1221. doi: 10.1016/j.fertnstert.2016.01.005. Epub 2016 Jan 27. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|