Rokitansky Kuster Hauser SyndromeNCT04314869
Uterus Transplantation Procedure From a Live Donor
A study testing Uterus transplantation in people with Rokitansky Kuster Hauser Syndrome and Sterility, Female, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Rokitansky Kuster Hauser Syndrome, Sterility, Female
- What is being tested?
- Uterus transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 23 May 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age <65 years.
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- 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
Who cannot join
- 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.
- Potential future pregnancy desire.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, 08036
Francisco Carmona, PhD
About this study
Official title: Feasibility Study of Uterus Transplantation Procedure From a Live Donor Obtaining the Graft by Laparoscopy
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.
Read the 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.
- Being tested
- Uterus transplantation
- Keywords
- minimally invasive surgery, uterus transplantation, living donor, absolut uterine factor
- Medical subject headings
- Mullerian aplasia, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterus transplantationProcedure or surgery
Also called Ovarian estimulation, Immunosupression treatment, Embryo transfer, C-section
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.
| Study group | Role | What they receive |
|---|---|---|
| Recipient | Experimental | Patient with absolut uterine factor will undergo uterus transplantation. Receives: Procedure: Uterus transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of grafts obtained by laparoscopy
It is feasible to obtain the graft by laparoscopy
Measured: 2 years
Secondary outcomes (1)
Number of healthy newborns
A healthy newborn after C-section
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start23 May 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rokitansky Kuster Hauser SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Carmona, Hospital Clinic of Barcelona
- Investigators
- Francisco Carmona, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314869
- Sponsor's protocol ID
- TUX2020
- Status last verified
- Nov 2020
- First submitted
- 17 Mar 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share individual participant data, but we will publish all the results and protocols so other researchers have access to this information
Publications
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.
PubMed 35058048
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Uterus Transplantation Procedure From a Live Donor Obtaining the Graft by Laparoscopy
- ClinicalTrials.gov ID
- NCT04314869
- Acronym / sponsor ID
- TUX2020
- Keywords
- minimally invasive surgery, uterus transplantation, living donor, absolut uterine factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 23 May 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recipient | Experimental | Procedure: Uterus transplantationPatient with absolut uterine factor will undergo uterus transplantation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterus transplantationAlso: Ovarian estimulation, Immunosupression treatment, Embryo transfer, C-sectionPatient 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. | Procedure or surgery | Recipient |
Primary outcome
Number of grafts obtained by laparoscopy
Time frame: 2 years
It is feasible to obtain the graft by laparoscopy
1 secondary outcome
Number of healthy newborns
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 35058048Diaz-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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Carmona, MD, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterus transplantation in people with Rokitansky Kuster Hauser Syndrome and Sterility, Female, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariona Rius, MD (932275400 ext. 5436, marius@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of grafts obtained by laparoscopy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04314869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.