Efficacy Study of the OV-Watch™ Personal Fertility Monitor for Women Using Clomiphene Citrate.
Completed
Conditions studied: Infertility, Anovulation, Polycystic Ovary Syndrome
In brief
The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict ovulation while women are taking clomiphene citrate.
Key facts
- Study ID
- NCT00239603
- Run by
- Emory University
- People needed
- 40
- Starts
- 2005-10-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2007-04-17
Who can join
Age: 21 and older, up to 42. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Emory Reproductive Center, Crawford Long Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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