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 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT02656550
Eligibility Criteria:
Inclusion Criteria:
1. Women diagnosed with Absolute Uterine Infertility (AUI) and intact native ovaries.
2. Women of childbearing age 20-35.
3. Human papillomarvius negative or received vaccination for human papillomarvius virus (HPV). Subjects with a history of HPV in the past must show a negative history since and test negative at screening.
4. A subject who is negative for Gonorrhea, Chlamydia and Syphilis.
5. A subject with the history of Herpes (HSV-2) with no current symptoms. Subject may require preventative maintenance per study doctor discretion.
6. Subjects have received counseling regarding infertility alternatives to uterine transplant such as adoption or surrogate pregnancy.
7. Willing to undergo in-vitro fertilization and medically cleared for in-vitro fertilization.
8. Evaluated by a fertility specialist and determined to have good ovarian reproductive potential and ability to carry fetus to term.
9. Must have the ability to fund, either through third party coverage or through other their own personal financing, any expenses associated with assisted reproduction services provided to them.
10. Meets physiological recipient criteria
Exclusion Criteria:
1. Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test.
2. Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or CellCept.
3. Subject with existing hypertension, per investigator's discretion.
4. Subject who has a history of solid organ or bone marrow transplant.
5. Subject who has history of cancer in last five years.
6. Subject with a body mass index \>30.
7. Subject with an active infection.
8. Subject who is seropositive for HIV, HBV, HCV
9. Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator.
10. Subject unwilling or unable to comply with study requirements.
11. Subject unable to undergo in-vitro fertilization or not cleared for transplant.
12. Subject who has smoked within the last 12 months.
13. Subject who has alcohol or drug abuse within 12 months of screening.
14. Subject with any pre-existing clinical or medical conditions that would pose the subject at an increased risk, as per the investigator's discretion.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT02656550
Study Brief:
Protocol Section:
NCT02656550