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The purpose of this study is to determine patient satisfaction and tolerability of the Evie® slow-release insemination device for US population. Additionally, to assess cramping with the device and to determine pregnancy rates using the slow insemination device compared to standard IUI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evie Slow-Release Insemination Device | Experimental | Preliminary studies in Europe have shown increased pregnancy rates using slow-release insemination. Evie slow-release insemination device is a device that is FDA approved. This device has been used in Europe, it has not yet been used at Carolinas Medical Center, by the Women's Institute. The technique for using this device involves loading a pump syringe with the prepared sperm, placing a balloon-secured catheter and syringe in the patient's sounded uterus, and connecting the insemination syringe to the catheter. The slow-release insemination occurs for 4 hours after the insertion of the catheter. The removal procedure, which can be performed by the patient if desired, involves deflating the catheter balloon and removing the catheter. |
|
| Traditional Intrauterine Insemination | Active Comparator | Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evie Slow-release Insemination Device | Device |
| ||
| Traditional Intrauterine Insemination |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Tolerability and Satisfaction SF36 | The primary outcome variable will be patient tolerability and satisfaction, based on a standardized SF-36 survey. Total score 0-100 with higher score denoting better outcomes | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Cramping | Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping. | 1 month |
| Pregnancy Rates | Pregnancy rates based on blood and urine beta-HCG. |
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The inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad Hurst, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Institute at Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1577936 | Background | Muharib NS, Abdel Gadir A, Shaw RW. Slow release intrauterine insemination versus the bolus technique in the treatment of women with cervical mucus hostility. Hum Reprod. 1992 Feb;7(2):227-9. doi: 10.1093/oxfordjournals.humrep.a137622. | |
| 19531445 | Background | Reindollar RH, Regan MM, Neumann PJ, Levine BS, Thornton KL, Alper MM, Goldman MB. A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial. Fertil Steril. 2010 Aug;94(3):888-99. doi: 10.1016/j.fertnstert.2009.04.022. Epub 2009 Jun 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Evie Slow-Release Insemination Device | Preliminary studies in Europe have shown increased pregnancy rates using slow-release insemination. Evie slow-release insemination device is a device that is FDA approved. This device has been used in Europe, it has not yet been used at Carolinas Medical Center, by the Women's Institute. The technique for using this device involves loading a pump syringe with the prepared sperm, placing a balloon-secured catheter and syringe in the patient's sounded uterus, and connecting the insemination syringe to the catheter. The slow-release insemination occurs for 4 hours after the insertion of the catheter. The removal procedure, which can be performed by the patient if desired, involves deflating the catheter balloon and removing the catheter. Evie Slow-release Insemination Device |
| FG001 | Traditional Intrauterine Insemination | Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene). Traditional Intrauterine Insemination |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Evie Slow-Release Insemination Device | Preliminary studies in Europe have shown increased pregnancy rates using slow-release insemination. Evie slow-release insemination device is a device that is FDA approved. This device has been used in Europe, it has not yet been used at Carolinas Medical Center, by the Women's Institute. The technique for using this device involves loading a pump syringe with the prepared sperm, placing a balloon-secured catheter and syringe in the patient's sounded uterus, and connecting the insemination syringe to the catheter. The slow-release insemination occurs for 4 hours after the insertion of the catheter. The removal procedure, which can be performed by the patient if desired, involves deflating the catheter balloon and removing the catheter. Evie Slow-release Insemination Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Tolerability and Satisfaction SF36 | The primary outcome variable will be patient tolerability and satisfaction, based on a standardized SF-36 survey. Total score 0-100 with higher score denoting better outcomes | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evie Slow-Release Insemination Device | Preliminary studies in Europe have shown increased pregnancy rates using slow-release insemination. Evie slow-release insemination device is a device that is FDA approved. This device has been used in Europe, it has not yet been used at Carolinas Medical Center, by the Women's Institute. The technique for using this device involves loading a pump syringe with the prepared sperm, placing a balloon-secured catheter and syringe in the patient's sounded uterus, and connecting the insemination syringe to the catheter. The slow-release insemination occurs for 4 hours after the insertion of the catheter. The removal procedure, which can be performed by the patient if desired, involves deflating the catheter balloon and removing the catheter. Evie Slow-release Insemination Device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley Hurst, M.D. | Atrium Health | 704-355-3153 | brad.hurst@atriumhealth.org |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Other |
|
| 3 months |
| 16000093 | Background | Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x. |
| Background | Short Form-36. Available at www.sf-36.org. Accessed on September 24, 2013. |
| BG001 | Traditional Intrauterine Insemination | Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene). Traditional Intrauterine Insemination |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Traditional Intrauterine Insemination | Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene). Traditional Intrauterine Insemination |
|
|
| Secondary | Cramping | Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping. | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
| Secondary | Pregnancy Rates | Pregnancy rates based on blood and urine beta-HCG. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Traditional Intrauterine Insemination | Traditional IUI is one of the treatment modalities for infertility that allows sperm to bypass the cervix and shortens the distance to the fallopian tubes for fertilization. The pregnancy rates for IUI with clomiphene citrate for couples with relatively unexplained infertility have been found to be 7.6% (for women 21-39 years old with up to 3 cycles of IUI with clomiphene). Traditional Intrauterine Insemination | 0 | 10 | 0 | 10 | 0 | 10 |
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