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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT00889512
Eligibility Criteria:
Inclusion Criteria:
1. 30 women under 38 years old at time of signing Informed Consent Form.
2. Evidence of hypothalamic amenorrhea (irregular menses and FSH and LH \<5 mIU/mL), uncorrected hyperprolactinemia (prolactin levels 10% above the upper limit of normal) or iatrogenic hypothalamic hypogonadism secondary to GnRHa suppression.
3. In good general health off of current medications which may confound response to study medications except GnRHa (Lupron Depot).
4. Desire to seek pregnancy actively during the study period.
5. A normal uterine cavity must have been confirmed by either hysteroscopy or hydrosonogram within two years of entering the study.
6. A semen analysis on the male partner deemed adequate for IVF by the attending physician within the past year or donor sperm available for insemination.
7. Only one treatment cycle per patient will be studied.
Exclusion Criteria:
1. uncorrected thyroid disease.
2. heart disease (New York Heart Association Class II or higher).
3. a history of, or suspected cervical, endometrial, or breast cancer. A normal Pap smear result within the last 24 months will be required.
4. enrolled into other studies that require medications, limit sex, or otherwise prevent compliance with the protocol at the same time.
5. to take other medications known to affect reproduction.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
38 Years
Study:
NCT00889512
Study Brief:
Protocol Section:
NCT00889512