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Sponsors and Collaborators: |
Emory University HealthWatchSystems, Inc. |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00239603 |
The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict ovulation while women are taking clomiphene citrate.
Condition | Intervention | Phase |
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Infertility Anovulation Polycystic Ovary Syndrome |
Device: OV-Watch |
Phase IV |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
Official Title: | Clinical Investigation of the OV-Watch™ Personal Fertility Monitor for Women Undergoing Ovulation Induction With Clomiphene Citrate. |
Estimated Enrollment: | 40 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | June 2007 |
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.
Ages Eligible for Study: | 21 Years to 42 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Emory Reproductive Center, Crawford Long Hospital | |
Atlanta, Georgia, United States, 30308 |
Principal Investigator: | Celia E Dominguez, MD | Emory Reproductive Center |
Study ID Numbers: | 867-2005 |
Study First Received: | October 13, 2005 |
Last Updated: | April 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00239603 History of Changes |
Health Authority: | United States: Institutional Review Board |
OV-Watch fertility monitor ovulation induction |
clomiphene citrate anovulation infertility |
Infertility Estrogen Antagonists Estrogens Gonadal Disorders Hormone Antagonists Citric Acid Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Clomiphene Ovarian Diseases Selective Estrogen Receptor Modulators |
Genital Diseases, Male Cysts Hormones Polycystic Ovarian Syndrome Genital Diseases, Female Estrogen Receptor Modulators Polycystic Ovary Syndrome Citrate Endocrinopathy Anovulation Ovarian Cysts |
Infertility Gonadal Disorders Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Clomiphene Ovarian Diseases Reproductive Control Agents Selective Estrogen Receptor Modulators Genital Diseases, Female Estrogen Receptor Modulators Pathologic Processes Therapeutic Uses Syndrome |
Estrogen Antagonists Disease Endocrine System Diseases Cysts Genital Diseases, Male Pharmacologic Actions Adnexal Diseases Neoplasms Fertility Agents, Female Polycystic Ovary Syndrome Fertility Agents Anovulation Ovarian Cysts |