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

Phase 4
21 Years
42 Years
Not Enrolling
Infertility, Anovulation, Polycystic Ovary Syndrome

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Trial Information

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

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

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.

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.

Type of Study:


Study Design:

Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Celia E Dominguez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory Reproductive Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

June 2007

Related Keywords:

  • Infertility
  • Anovulation
  • Polycystic Ovary Syndrome
  • OV-Watch
  • fertility monitor
  • ovulation induction
  • clomiphene citrate
  • anovulation
  • infertility
  • Anovulation
  • Infertility
  • Polycystic Ovary Syndrome



Emory Reproductive Center, Crawford Long HospitalAtlanta, Georgia  30308