Infertility
Conditions
Keywords
Infertility, Intrauterine Insemination, Slow-release Insemination, Evie
Brief summary
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.
Interventions
DEVICEEvie Slow-release Insemination Device
OTHERTraditional Intrauterine Insemination
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
The inclusion criteria: * Infertile women age ≤39 undergoing first IUI cycle for relatively unexplained infertility * IRB approval and informed consent signed
Exclusion criteria
* Women \<18 or ≥40 years old * Women with abnormalities of the uterine cavity * Women with tubal occlusion * History of documented pelvic adhesions or endometriosis * Uncorrected ovulatory dysfunction * Uncorrected thyroid function * AMH \<1 ng/mL * \<5 million total motile sperm expected for insemination in prior analyses or on the day of sperm preparation for insemination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Tolerability and Satisfaction SF36 | 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cramping | 1 month | Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping. |
| Pregnancy Rates | 3 months | Pregnancy rates based on blood and urine beta-HCG. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Evie Slow-Release Insemination Device | Traditional Intrauterine Insemination | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 10 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 10 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 10 Participants | 22 Participants |
| Region of Enrollment United States | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
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
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evie Slow-Release Insemination Device | Patient Tolerability and Satisfaction SF36 | 76.8 units on a scale | Standard Deviation 15.9 |
| Traditional Intrauterine Insemination | Patient Tolerability and Satisfaction SF36 | 84.2 units on a scale | Standard Deviation 11.28 |
Secondary
Cramping
Cramping assessment based on a Numerical Rating Scale 0 to 10. Higher score denotes worse cramping.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evie Slow-Release Insemination Device | Cramping | 3.85 score on a scale | Standard Deviation 2 |
| Traditional Intrauterine Insemination | Cramping | 2.42 score on a scale | Standard Deviation 1.93 |
Secondary
Pregnancy Rates
Pregnancy rates based on blood and urine beta-HCG.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evie Slow-Release Insemination Device | Pregnancy Rates | 4 Participants |
| Traditional Intrauterine Insemination | Pregnancy Rates | 3 Participants |