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:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT01408433
Eligibility Criteria:
Inclusion Criteria:
1. Maximum of one (1) prior failed IVF cycle (a failed cycle is any cycle that did not deliver. Pregnancy losses are failed cycles. Ok to participate as a recipient in an egg donor cycle.)
2. Female partner less than 43 years old at time of onset of IVF cycle
3. Maximum prior day 3 follicle stimulation hormone (FSH) level of 12 (in RMA NJ laboratory)
4. Minimum anti-mullerian hormone (AMH)of 1.2 within 1 year
5. Normal uterine cavity demonstrated by saline sonogram, hysterosalpingogram or hysteroscopy within 1 year.
6. Male partner with greater than 100,000 total motile spermatozoa. Donor sperm ok.
7. Body Mass Index (BMI) less than or equal to 30 kg/m2.
Exclusion Criteria:
1. Diagnosis of chronic anovulation (cycles typically longer than 90 days)
2. Diagnosis of endometrial insufficiency- prior cycle with endometrial thickness less than 6mm, abnormal endometrial echotexture, persistent endometrial fluid.
3. Clinical indication of aneuploidy screening (i.e. history of loss of chromosomally abnormal pregnancies)
4. Clinical indication for PGD for single-gene disorder (i.e. PGD is needed to select against the transfer of embryos affected with a specific condition)
5. Use of testicular aspiration or biopsy procedures to obtain sperm
6. Unevaluated ovarian mass or surgically confirmed stage IV endometriosis
7. Presence of hydrosalpinges which communicate with the endometrial cavity
8. Any contraindication to undergoing in vitro fertilization
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
43 Years
Study:
NCT01408433
Study Brief:
Protocol Section:
NCT01408433