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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT02741102
Eligibility Criteria:
Uterine Transplant Inclusion/Exclusion Criteria
RECIPIENT:Inclusion Criteria
* Age 18-40
* Clinical evidence of AUFI (Absolute Uterine Factor Infertility)
* Able to produce at least 6 normal embryos by IVF for future use
* Reasonable weight with BMI (Body Mass Index) less than 30.
* Normal kidney function
* Able to undergo transplant and be compliant with treatment
* Has stable partner and social supports
* Partner willing to undergo psychological evaluation and receive immunizations as recommended
* Stable home environment to support a child
Exclusion Criteria :
* Active smoking, alcohol use or use of illicit drugs
* Inability to comply with required treatment (taking pills, having biopsies, frequent appointments )
* Having a condition that would make pregnancy or taking anti rejection medicines too risky.
* Active infection: Human Immunodeficiency Virus (HIV) , Tuberculosis, Hepatitis B, Hepatitis C
* History of extensive abdominal or pelvic surgery
* History of abnormal Papanicolaou test (PAP smear) or genital warts
* History of pelvic inflammatory disease
DONOR:Inclusion criteria
* Age over 40 up to age 60
* Has completed having a family
* Previous pregnancies were carried to term (no miscarriages)
* Able to take a birth control pill containing estrogen
* Weight reasonable with BMI (Body Mass Index) of 30 or less
* Good social supports
Exclusion Criteria:
* Active smoking, alcohol use or use of illicit drugs
* Psychiatric illness
* Cervical or endometrial polyps (growths) or tumors in the uterus muscle
* History of more than 1 Caesarean section
* History of abnormal PAP smear or genital warts
* Internal scarring from extensive abdominal or pelvic surgery
* Hypertension, Coronary artery disease, Chronic Obstructive Lung disease (emphysema) and Diabetes
* Active cancer or incompletely treated cancer
* Active infection including Human Immunodeficiency Disease (HIV) , Tuberculosis, Hepatitis B or Hepatitis C
* Significant history of either blood clots or bleeding tendencies
* Evidence of coercion or exchange of money or goods for donating the organ
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02741102
Study Brief:
Protocol Section:
NCT02741102