Efficacy Study of the OV-Watch™ Personal Fertility Monitor for Women Using Clomiphene Citrate.
|Infertility Anovulation Polycystic Ovary Syndrome||Device: OV-Watch||Phase 4|
|Study Design:||Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
|Official Title:||Clinical Investigation of the OV-Watch™ Personal Fertility Monitor for Women Undergoing Ovulation Induction With Clomiphene Citrate.|
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||June 2007|
At any given time, there are 10-15% of American couples with infertility. A problem with ovulation (releasing an egg) is one of the most common causes of female infertility. The frequency and timing of intercourse is important because the best chance of pregnancy occurs around the time of ovulation. The days that pregnancy is most likely to occur with intercourse is referred to as the "fertile window".
The fertile window lasts for 6 days. It starts 4 days before ovulation and continues through the day after ovulation. Intercourse on the day of ovulation gives the highest chance of getting pregnant. However, intercourse up to 4 days before ovulation can still result in pregnancy because sperm can survive for up to 6 days in the reproductive tract of a woman.
Urinary testing for the luteinizing hormone (LH) surge is the most common method for predicting ovulation. The LH surge precedes ovulation by about 36 hours. When LH is detected, this gives a couple only 2 days to have intercourse that may result in fertilization.
The OV-Watch is an FDA approved device that has been shown to predict ovulation 5 days in advance for women who ovulate regularly. This wristwatch-like device is worn daily to detects changes in sweat ions. The device allows for earlier detection of the fertile window, giving the couple more opportunities to conceive.
For women who do not ovulate on their own or ovulate irregularly, medication can be taken to help make eggs and ovulate. Clomiphene citrate is the most commonly used medication for this. We plan to study the effectiveness of the OV-Watch in women who are undergoing ovulation induction with clomiphene citrate and will compare the results to standard urinary LH testing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239603
|United States, Georgia|
|Emory Reproductive Center, Crawford Long Hospital|
|Atlanta, Georgia, United States, 30308|
|Principal Investigator:||Celia E Dominguez, MD||Emory Reproductive Center|