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

This study has been completed.
Sponsor:
Collaborator:
HealthWatchSystems, Inc.
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00239603
First received: October 13, 2005
Last updated: April 16, 2007
Last verified: April 2007
  Purpose

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
Infertility
Anovulation
Polycystic Ovary Syndrome
Device: OV-Watch
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Clinical Investigation of the OV-Watch™ Personal Fertility Monitor for Women Undergoing Ovulation Induction With Clomiphene Citrate.

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 40
Study Start Date: October 2005
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239603

Locations
United States, Georgia
Emory Reproductive Center, Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
HealthWatchSystems, Inc.
Investigators
Principal Investigator: Celia E Dominguez, MD Emory Reproductive Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00239603     History of Changes
Other Study ID Numbers: 867-2005
Study First Received: October 13, 2005
Last Updated: April 16, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
OV-Watch
fertility monitor
ovulation induction
clomiphene citrate
anovulation
infertility

Additional relevant MeSH terms:
Infertility
Fertility Agents, Female
Fertility Agents
Anovulation
Polycystic Ovary Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Genital Diseases, Male
Ovarian Cysts
Cysts
Neoplasms
Clomiphene
Enclomiphene
Zuclomiphene
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on August 28, 2014