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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recipient | Experimental | Patient with absolut uterine factor will undergo uterus transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterus transplantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of grafts obtained by laparoscopy | It is feasible to obtain the graft by laparoscopy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of healthy newborns | A healthy newborn after C-section | 5 years |
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Inclusion Criteria Recipient:
Exclusion Criteria Recipient:
Inclusion Criteria donor:
Exclusion Criteria donor:
It is a uterus transplantation program, it only includes women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariona Rius, MD | Contact | 932275400 | 5436 | marius@clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Carmona, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Recruiting | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35058048 | Derived | Diaz-Feijoo B, Rius M, Gracia M, Musquera M, Magaldi M, Peri L, Alcaraz A, Carmona F. Donor robotic-assisted laparoscopy for uterus transplantation. Fertil Steril. 2022 Mar;117(3):651-652. doi: 10.1016/j.fertnstert.2021.11.026. Epub 2022 Jan 17. |
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We will not share individual participant data, but we will publish all the results and protocols so other researchers have access to this information
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| ID | Term |
|---|---|
| C537371 | Mullerian aplasia |
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004624 | Embryo Transfer |
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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|
|
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |