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 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT01331395
Eligibility Criteria:
Inclusion Criteria:
1. Subject is able to understand and provide consent
2. Subject is female, 21-42 years of age at time of screening and has at least one l ovary
3. Subject BMI is \> 18 and \< 32
4. Subject is experiencing primary or secondary infertility
5. Subject may receive sperm from donated source
6. Subject's partner has sperm in the ejaculate
7. Subject's serum basal FSH is \< 11 IU/L
8. Subject's serum basal estradiol level is between 20-80 pg/mL
9. Subject's TSH level is \< 3.0 mv/mL
10. Subject's prolactin level is \< 24 ng/mL
11. Subject will agree to limit caffeine intake to one cup (76.5 mL/day) by the time of randomization
12. Subject agrees not to make alterations in diet and lifestyle practices other than those that their Medical Practitioner deems necessary in the best interest of the subject
13. Subject agrees not to participate in any other research opportunities for the duration of the study
Exclusion Criteria:
1. Subject is pursuing sex selection
2. Subject is undergoing treatment with an egg donor
3. Subject experienced more than 2 previous failed cycles
4. Subject is undergoing a heparin or lovenox-based protocol
5. Subject is currently taking herbal therapy (1 week wash-out)
6. Subject is currently taking co-interventions of moxibustion and cupping
7. Subject is exhibiting uterine anomalies (i.e.,bicornuate, unicornuate uterus,)
8. Subject is diagnosed with severe endometriosis defined as endometriomas \> 4cm
9. Subject is currently receiving acupuncture therapy (Subject must agree to a 30 day washout period prior to randomization)
10. Subject has history of recurrent spontaneous abortions defined as \> 3
11. Subjects with a Beck Depression Inventory (BDI-II) of 29 or higher at screening, indicative of severe depression, will be excluded from the study and referred for further psychological evaluation by our in-house licensed mental health professional.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
42 Years
Study:
NCT01331395
Study Brief:
Protocol Section:
NCT01331395