Rokitansky Kuster Hauser Syndrome, Sterility, Female
Conditions
Keywords
minimally invasive surgery, uterus transplantation, living donor, absolut uterine factor
Brief summary
Absolut uterine factor, meaning the absence of uterus, represents a cause for sterility without the possibility of a present treatment. The uterine factor affects millions of women and may be due to congenital problems, such as the Muller anomalies (Mayer Rockitansky Syndrome) or acquired by previous hysterectomy or intrauterine adhesions (Asherman's Syndrome). The uterine transplant would represent the only possibility for patients with an absolute uterine factor to achieve both genetic and gestational maternity.
Detailed description
To obtain by laparoscopy a viable uterus for transplantation from a living donor is feasible. The laparoscopic procedure increases safety and provides the benefits of minimally invasive surgery to the grafting technique already described by laparotomy. The objective of the present study is to develop a pilot program in the transplant of a living donor. We include 5 pairs of uterine donor-transplant recipients indicated for sterility by absolute uterine factor due to Mayer Rokitansky Syndrome. Patients will undergo surgery for this transplant and after 6 months of it with correct function of the graft, embryos will be transferred in order to achieve pregnancy. C-section will be performed for delivery. The attempt of two gestations (if there are sufficient cryopreserved embryos for a second gestation) and withdrawing the graft (hysterectomy) and, therefore, immunosuppression is agreed.
Interventions
PROCEDUREUterus transplantation
Patient will undergo surgery in order to transplant the graft (uterus). After that, a follow-up in order to detect early rejection. After 6 months, embryo transfer will be perfomed. Labour route will be C-Section. Two pregnancies are agreed, and after the second one, a hysterectomy will be performed in order to remove the graft.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of grafts obtained by laparoscopy | 2 years | It is feasible to obtain the graft by laparoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of healthy newborns | 5 years | A healthy newborn after C-section |
Countries
Spain
Contacts
Primary ContactMariona Rius, MD
Outcome results
None listed