Official Title: “Clinical Investigation of the OV-Watch™ Personal Fertility Monitor for Women Undergoing Ovulation Induction With Clomiphene Citrate.”

The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict ovulation while women are taking clomiphene citrate.

Study Type: Observational

Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

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.

Intervention(s) in this Clinical Trial

• Device: OV-Watch

Inclusion Criteria:

• Patients eligible to participate must be between the age of 21 and 42.
• Patient must demonstrate ability to follow standard clomiphene citrate ovulation induction protocol and wear the OV-Watch™ correctly.
• Intact uterus and at least one ovary must be present.
• Patients must be diagnosed with anovulation (lack of ovulation) that is not caused by hypothalamic amenorrhea or premature ovarian failure.
• A hysterosalpingogram must be performed to demonstrate at least one patent fallopian tube. The uterine cavity must also appear normal on this study.
• The male partner or sperm donor must demonstrate an acceptable concentration and motility of sperm.

Exclusion Criteria:

• 12 or more previous treatment cycles using clomiphene citrate.
• Any condition where the use of clomiphene is contraindicated, such as breast cancer or liver disease.
• Any other hormonal disease that may be secondarily causing anovulation, such as thyroid disorder or hyperprolactinemia.
• Amenorrhea caused by premature ovarian failure or hypothalamic amenorrhea.
• Any active genital tract infection will need to be treated with antibiotics before undergoing ovulation induction.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 42 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Emory University

Overall Clinical Trial Officials and Contacts

Celia E Dominguez, MD Principal Investigator Emory Reproductive Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00239603

Study ID Number: 867-2005

ClinicalTrials.gov Identifier: NCT00239603

Health Authority: United States: Institutional Review Board