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The purpose of this study is to determine if the use of slush nitrogen results in higher post-thaw survival rates for oocytes compared to conventionally used liquid nitrogen.
The study is a randomized, controlled trial which seeks to characterize oocyte survival rate following vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, fertilization and embryology outcomes will be assessed.
Oocyte donors and a single donor sperm source will be utilized. Following enrollment, oocyte donors will undergo ovarian stimulation and oocyte retrieval. The mature (MII) oocytes obtained for each patient will then be assigned a number and randomized via block randomization to one of two treatment groups (liquid nitogen or slush nitrogen). Through block randomization, this will create a paired population of oocytes so that half of each patient's oocytes will undergo cryopreservation with liquid nitrogen and half will undergo cryopreservation with slush nitrogen. Timing of hyaluronidase stripping and vitrification will be consistent with current institutional clinical practice for oocytes.
Following cryopreservation, oocytes will be warmed and intracytoplasmic sperm injection will be performed and subsequent embryology outcomes tracked.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slush nitrogen | Active Comparator | oocytes are randomized to undergo vitrification utilizing slush nitrogen |
|
| Liquid Nitrogen | Active Comparator | oocytes are randomized to undergo vitrification utilizing liquid nitrogen which is the current standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrification via slush nitrogen | Other | oocytes will be vitrified using slush nitrogen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| oocyte survival rate | number of viable oocytes post warming | within 5 minutes post warming |
| Measure | Description | Time Frame |
|---|---|---|
| fertilization rate | number of zygotes post intracytoplasmic sperm injection procedure | 18 hours post injection |
| blastulation rate | number of zygotes reaching the blastocyst stage of embryo development |
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Major Inclusion Criteria for oocyte donors:
Major Exclusion Criteria for oocyte donors:
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| 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 |
|---|---|---|---|
| 34654569 | Derived | Hanson BM, Kim JG, Suarez SI, Ackerman BK, Comito CE, Pangasnan R, Seli E, Hong KH, Scott RT Jr. Embryology outcomes after oocyte vitrification with super-cooled slush nitrogen are similar to outcomes with conventional liquid nitrogen: a randomized controlled trial. Fertil Steril. 2022 Jan;117(1):106-114. doi: 10.1016/j.fertnstert.2021.08.043. Epub 2021 Oct 13. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Randomized Controlled Trial in a paired design
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embryologist assessing oocyte survival (primary outcome) is blinded
| Vitrification via liquid nitrogen |
| Other |
oocytes will be vitrified using liquid nitrogen which is currently routine practice |
|
| 4-6 days after fertilization |
| euploid rate | number of chromosomally normal embryos | 1 week after trophectoderm biopsy |