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| Name | Class |
|---|---|
| The Center for Advanced Reproductive Services, P.C. | OTHER |
| ZyMot Fertility | UNKNOWN |
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This research is being done to determine if using a microfluidics chamber, a device used to process sperm, will be effective in improving the rates of embryos with normal chromosomes (structures that carry genetic information) during in vitro fertilization (IVF) treatment. The investigators hypothesize that this device is effective at improving rates of normal chromosomes among embryos.
As part of the in vitro fertilization (IVF) process, eggs are removed from the ovaries and are inseminated (mixed) or injected with sperm. In order for fertilization to occur, the sperm cells must be separated from the semen before introducing them to the eggs. Currently, sperm are isolated from the semen using a series of wash steps in a centrifuge (device to spin and concentrate the sperm). This requires processing at high speeds in order to separate motile sperm from the other parts of the semen. Although it is common practice, it is possible that this method of processing the semen may cause damage to the sperm cells.
Alternatively, a microfluidics chamber can be used to choose the best sperm. A microfluidics chamber is a small device in which the unwashed sperm can be placed at one end. Sperm that are moving forward will swim through the chamber and come out the other end. Dead sperm are left behind and the sperm with the best motility (how normally they move forward) and normal morphology (how the sperm looks) will make it to the other end of the chamber. These sperm can then be chosen for injection into the egg. This device is FDA-approved for this purpose and is commercially available and is currently routinely used in the IVF lab utilized by the investigators as well as most labs in the country.
Some small initial studies showed that a higher number of embryos with higher quality were made with sperm selected from a microfluidics chamber. In another recent study, the chances of creating an embryo with a normal number of chromosomes (structures that carry genetic information) was also slightly higher if a microfluidics chamber was used to process the sperm. This might be because sperm that have the highest motility and normal morphology may also be more likely to be genetically normal. However, there are no good-quality studies looking at the rates of embryos with normal chromosomes created from using a microfluidics chamber to process sperm.
The purpose of this research study is to determine whether using a microfluidics chamber to process sperm for injection into eggs increases the rates of embryos with normal chromosomes. At the time of egg retrieval, participants will have their eggs randomized (like the flip of a coin) into two groups. Half of the eggs will be injected with sperm processed using gradient centrifugation, the standard method. The other half of the eggs will be injected with sperm processed using a microfluidics chamber. The goal is to determine the rate of embryos with normal chromosomes in each group. Other goals include looking at how many embryos develop to good quality blastocysts and are biopsied and how many patients get pregnant after embryo transfer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microfluidics | Experimental | Half of participants eggs will be injected with sperm processed using a microfluidics chamber. |
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| Density gradient centrifugation | Active Comparator | Half of participants eggs will be injected with sperm processed using a density gradient centrifugation (the standard method). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microfluidics chamber | Device | Unwashed sperm will be placed into the inlet chamber of the microfluidics device. The most motile sperm will swim to the outlet chamber, and these sperms will be used for intracytoplasmic sperm injection (ICSI) into the eggs. |
| Measure | Description | Time Frame |
|---|---|---|
| Euploidy rate of resulting embryos | Rate of embryos with normal chromosomes in both groups | Within 2-4 weeks of IVF cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rates after transfer of euploid embryos | Pregnancy rate after one euploid embryo (from either experimental or control group) is transferred back into the participant in a subsequent cycle | Within 1-2 cycles of fresh IVF cycle |
| Measure | Description | Time Frame |
|---|---|---|
| DNA fragmentation results | Compare DNA fragmentation results between groups | 1-2 years after initial study completed |
Inclusion criteria:
Exclusion criteria:
Nonpregnant females underoing in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT)
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Engmann, MD | UConn Health | Principal Investigator |
| Alison Bartolucci, PhD | The Center for Advanced Reproductive Services, P.C. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Advanced Reproductive Services | Farmington | Connecticut | 06032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38367686 | Derived | Godiwala P, Kwieraga J, Almanza E, Neuber E, Grow D, Benadiva C, Makhijani R, DiLuigi A, Schmidt D, Bartolucci A, Engmann L. The impact of microfluidics sperm processing on blastocyst euploidy rates compared with density gradient centrifugation: a sibling oocyte double-blinded prospective randomized clinical trial. Fertil Steril. 2024 Jul;122(1):85-94. doi: 10.1016/j.fertnstert.2024.02.021. Epub 2024 Feb 15. |
| Label | URL |
|---|---|
| The Center for Advanced Reproductive Services Website | View source |
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Undecided at this time, may be available upon request in the future
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 28, 2025 | Jul 16, 2025 | 4 |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002499 | Centrifugation, Density Gradient |
| ID | Term |
|---|---|
| D014461 | Ultracentrifugation |
| D002498 | Centrifugation |
| D008919 | Investigative Techniques |
| D002623 | Chemistry Techniques, Analytical |
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Sibling oocyte study: Participants will have their oocytes (eggs) divided into two groups. Half of the eggs will be injected with sperm processed in the normal way, and half will be injected with sperm processed via a microfluidics chamber.
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Participants, clinical providers, investigators and Outcome assessors will be blinded to outcomes.
|
| Density Gradient Centrifugation | Other | Sperm will be washed and centrifuged according to standard protocol, and these washed sperm will be used for ICSI. |
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