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

April 16, 2007 updated by: Emory University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Reproductive Center, Crawford Long Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

HealthWatchSystems, Inc.

Investigators

  • Principal Investigator: Celia E Dominguez, MD, Emory Reproductive Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

April 17, 2007

Last Update Submitted That Met QC Criteria

April 16, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 867-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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