Status:
COMPLETED
Efficacy Study of the OV-Watch™ Personal Fertility Monitor for Women Using Clomiphene Citrate.
Lead Sponsor:
Emory University
Collaborating Sponsors:
HealthWatchSystems, Inc.
Conditions:
Infertility
Anovulation
Eligibility:
FEMALE
21-42 years
Brief Summary
The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict ovulation while women are taking clomiphene citrate.
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
End Date :
June 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00239603
Start Date
October 1 2005
End Date
June 1 2007
Last Update
April 17 2007
Active Locations (1)
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1
Emory Reproductive Center, Crawford Long Hospital
Atlanta, Georgia, United States, 30308