Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to determine the performance of a salivary hormone competitive immunoassay for monitoring patients during treatment for infertility.
The goal of this study is to determine the performance of a salivary hormone competitive immunoassay for monitoring patient estrogen and progesterone levels during treatment for infertility using controlled ovarian stimulation (COH) and in vitro fertilization (IVF). Specifically, inter- and intra-assay precision, correlation with serum measurements (the gold-standard), and user satisfaction will be determined. Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infertility | Patients undergoing ovulation induction and controlled ovarian hyperstimulation at a participating infertility center |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence of Salivary Steroid Monitoring to Blood Based Monitoring | The potential applicability and reliability of salivary steroid monitoring during infertility treatment will be measured as a progression during a patient's IVF stimulation cycle. Concurrent saliva and blood draw measurements of Estradiol and Progesterone will be taken between 3-5 times during a 2-week monitoring period. Equivalence will be determined by the matched progression of Estradiol and progesterone levels (pg/ml) in the same patient at the concurrent times. Saliva Estradiol and Progesterone levels are of a magnitude of 100-200 less than serum based values and are converted using an algorithm to adjust to serum equivalence. Matched T-test will be used to test the hypothesis that the two methods are not statistically different. | 1 month |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alison Zimon, MD | Boston IVF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HRC Fertility | Pasadena | California | 91105 | United States | ||
| Reproductive Biology Associates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Fertility Center of Illinois | Chicago | Illinois | 60610 | United States |
| Boston IVF | South Portland | Maine | 04106 | United States |
| Shady Grove Fertility Reproductive Science Center | Rockville | Maryland | 20850 | United States |
| Boston IVF | Quincy | Massachusetts | 02169 | United States |
| Boston IVF | Waltham | Massachusetts | 02451 | United States |
| Reproductive Medicine Associates of New York, LLP | New York | New York | 10022 | United States |