- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00239603
Efficacy Study of the OV-Watch™ Personal Fertility Monitor for Women Using Clomiphene Citrate.
Clinical Investigation of the OV-Watch™ Personal Fertility Monitor for Women Undergoing Ovulation Induction With Clomiphene Citrate.
Study Overview
Status
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
Enrollment
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory Reproductive Center, Crawford Long Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Celia E Dominguez, MD, Emory Reproductive Center
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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