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This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.
Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Density gradient centrifugation | Active Comparator | Patients will undergo sperm preparation by density gradient centrifugation |
|
| Zymot sperm separation device | Active Comparator | Patients will undergo sperm preparation by the Zymot sperm separation device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zymot Multi sperm separation device | Device | Sperm preparation with Zymot Multi sperm preparation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative clinical pregnancy rate | The clinical pregnancy rate by treatment group over the course of IUI treatment | 3 treatment cycles, an average of 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alisha T Tolani, MD | Contact | 6282867307 | alisha.tolani@ucsf.edu | |
| Elena Hoskin | Contact | elena.hoskin@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell Rosen, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Center for Reproductive Health | Recruiting | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31543253 | Background | Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19. | |
| 30007319 | Background |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D000858 | Anovulation |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal 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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| Density gradient centrifugation | Other | Sperm preparation with density gradient centrifugation |
|
| Quinn MM, Jalalian L, Ribeiro S, Ona K, Demirci U, Cedars MI, Rosen MP. Microfluidic sorting selects sperm for clinical use with reduced DNA damage compared to density gradient centrifugation with swim-up in split semen samples. Hum Reprod. 2018 Aug 1;33(8):1388-1393. doi: 10.1093/humrep/dey239. |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |