Efficacy Study of the OV-Watch™ Personal Fertility Monitor for Women Using Clomiphene Citrate.

Original Study ID : 867-2005

NCT ID : NCT00239603

Brief Title : Efficacy Study of the OV-Watch™ Personal Fertility Monitor for Women Using Clomiphene Citrate.

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

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

Source : Emory University

Detailed Description :
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.

Overall Status : Completed

Start Date : October 2005

End Date : June 2007

Completion Date : June 2007

Official Title : Phase 4

Phase : Observational

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

Enrollment : 40

Verification Date : April 2007

First Received Date : October 13, 2005

Trial Eligibility

Criteria :
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 : Female

Minimum Age : 21 Years

Maximum Age : 42 Years

Healthy Volunteers : Accepts He

Facilities

Facility Name : Emory Reproductive Center, Crawford Long Hospital

City : Atlanta

State : Georgia

Zip Code : 30308

Country : United States

Clinical Trial Name -Efficacy Study of the OV-Watch™ Personal Fertility Monitor for Women Using Clomiphene Citrate.