Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT00239603
Eligibility 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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
42 Years
Study:
NCT00239603
Study Brief:
Protocol Section:
NCT00239603