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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT04314869
Eligibility Criteria:
Inclusion Criteria Recipient:
* Patient with sterility for absolute uterine factor (malformation or previous surgery for benign processes).
* Age \<40 years.
* Absence of pathology that contraindicates a complex surgical process, immunosuppression or gestation.
* Positive results to the IVF cycle prior to the surgery, obtaining quality embryos.
* Acceptance to participate in the study signing the informed consent.
Exclusion Criteria Recipient:
* Medical or surgical pathology that contraindicates a complex pelvic surgical procedure.
* Medical conditions that contraindicate, may aggravate or complicate the immunosuppressor treatment, such as neoplastic or preneoplasic diseases, chronic infectious diseases, autoimmune diseases, renal or liver failure.
* Medical or surgical pathology that contraindicates pregnancy.
* Anatomic alterations or vascular pathology that might difficult the vascular anastomosis: severe endometriosis, pelvic kidney, severe adherence syndrome or others.
* Uncontrolled psychopathology.
Inclusion Criteria donor:
* Age \<65 years.
* First- or second-degree relatives.
* Completed reproductive desire.
* History of previous pregnancies and births.
* Absence of associated pathology that contraindicates prolonged and complex laparoscopic surgery (pneumopathies, heart disease, morbid obesity, …).
* Acceptance to participate in the study signing the informed consent
Exclusion Criteria donor:
* Potential future pregnancy desire.
* Surgery for the treatment of gender identity disorder.
* Infections: HIV or risk group, HBV-DNA and / or HBsAg positive, positive HCV, active bacterial sepsis, infections with multi-resistant bacteria, active tuberculosis or incomplete treatment of the same, Chagas disease, untreated active viral infections.
* Active malignant cancer of any location, except skin basal cell carcinoma. Treated cancer without current evidence of illness but with a follow-up of less than 5 years.
* Benign pelvic pathology: uterine fibroids, uterine malformations, severe endometriosis, severe adherence syndrome.
* Vascular pathology: malformations, atheromatosis, hypertensive or diabetic vasculopathy, connective tissue disease with vascular involvement.
* Premalignant pelvic pathology: pre-invasive cervical and/or vaginal, endometrial hyperplasia.
* BRCA mutation carriers or genes related to Lynch syndrome.
* History of implantation failure or multiple abortions of unknown cause.
* Contraindications for the surgical procedure of donation through laparoscopy: diabetes mellitus, liver disease, nephropathy, heart disease, pneumopathy, morbid obesity or high-risk cardiovascular factors.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04314869
Study Brief:
Protocol Section:
NCT04314869