Uterine Factor InfertilityTULIPENCT05726305
Transplantation of Uterus for Uterine infertiLIty From Living Donor or Deceased Donor
A study testing Live donor uterus transplantation and Deceased donor uterus transplantation in people with Uterine Factor Infertility, run by Rennes University Hospital at 1 site in France.
Trial summary
Patients with absolute Uterine Factor Infertility (AUFI) are infertile due to the absence of a uterus. The absence of a uterus can be either iatrogenic (hysterectomy for gynecological pathology such as cancer or for obstetric pathology such as postpartum hemorrhage with hysterectomy for hemostasis), or congenital with… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Factor Infertility
- What is being tested?
- Live donor uterus transplantation and Deceased donor uterus transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2024to Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient aged 18 to 40 at the time of the UT;
- BMI (Body Mass Index) ≤ 30 kg/m²;
- With AUFI (type 1 or 2 MRKH syndrome and hysterectomy);
- Informed about the possibility of adoption;
- Compatibility with the donor (ABO group, Human Leukocyte Antigen (HLA) typing);
- Up-to-date vaccinations;
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- Able to reach the transplant center in less than 11 hours (applicable only for the "deceased donor" arm);
- Having a parental project that is formulated by a heterosexual couple, by a couple of women or by a single woman;
- Vaginal cup of length greater than or equal to 7 cm.
- Any person who is brain dead and who has been duly diagnosed with the following criteria: Female gender;Age ≤ 42 years;Compatibility with the recipient (ABO group, HLA typing).
- Patient belonging to the family of the recipient (mother, sister, aunt, mother-in-law...) or any person who can prove a stable emotional relationship for more than 2 years with the recipient (paragraphs 1 and 2 of Article L.1231-1 of the Public Health Code);
- Age ≥ 37 years and ≤ 62 years ;
- BMI ≤ 30 kg/m²;
- Having completed all her parenthood plans and no longer having any plans of pregnancy;
- Having had at least one live-born child at term (i.e. after 37 weeks of of amenorrhea);
- Compatibility with the recipient (ABO group, HLA typing);
- Normal suprapubic and/or endovaginal ultrasound or pelvic Magnetic Resonance Imaging (MRI), including uterine (no uterine abnormalities);
- Satisfactory uterine vessels assessed by MRI angio.
Who cannot join
- Patient with acquired uterine infertility and having had one or more children;
- Non-stable psychological state defined by a clinical psychologist after a qualitative interview;
- Severe co-morbidity;
- Association of severe abnormality with MRKH syndrome other than renal such as a cardiac malformation;
- A single pelvic kidney (urinary malformation that can be associated with MRKH syndrome);
- Pathogenic parental genetic anomaly which may lead to medical termination of pregnancy in the current state of knowledge;
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- Diabetes (HbA1c > 6%);
- Disorders of hemostasis: Prothrombin rate <70%;
- Hemoglobin abnormality;
- Existence of hypertension;
- Vaginal reconstruction (neovagina) by digestive segment (colonic plastic surgery or other);
- History of major abdominal or pelvic surgery;
- Known thrombophilia (acquired or constitutional);
- HIV (Human Immunodeficiency Virus), HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), HAV (Hepatitis A Virus), HTLV (Human T-Lymphotropic Virus) serology positive and presence of irreversible communicable infectious diseases;
- Positive vaginal hPV-HR (human Papilloma Virus High Risk) test;
- Signs of chronic renal disease;
- Drug addiction or alcoholism not weaned for more than 2 years or drug addiction or excessive alcohol consumption (> 30 g/day of alcohol) current;
- History of cancer less than 10 years old, cancer under treatment (except in the cancer in situ, or basal cell skin lesion) or diagnosed during the selection process;
- History of pelvic radiotherapy or vaginal brachytherapy regardless of when this irradiation was performed;
- Known psychiatric pathology;
- Active tuberculosis (i.e. under treatment);
- Known or suspected contraindications to one or more of the treatments (active substance or excipient(s)) to be administered for the purposes of the study and/or essential treatment having an interaction/impact with one of the treatments planned by the research;
- Existence of organ dysfunction not compatible with the uterine transplantation protocol;
- History of smoking (defined as consumption greater than 20 packs/year) not weaned for more than 2 years or active smoker.
- Initial circulatory arrest of more than 10 minutes;
- Opposition to organ donation (register of refusals) or to uterine removal by a relative of the deceased;
- Chronic and uncontrolled hypertension;
- Absence of uterus (history of hysterectomy or uterine agenesis);
- Presence of uterine pathology;
- Delivery less than 6 months ago or ongoing pregnancy;
- History of several caesarean sections (multi-scarred uterus: more than 2);
- History of major abdominal or pelvic surgery;
- Infection of the sepsis type or uncontrolled infection (bacterial, viral viral, parasitic fungal, active Chagas disease);
- Encephalitis of viral origin or febrile of uncertain origin or meningoencephalitis of unknown origin;
- Risk of Prion disease transmission;
- Presence of an infectious disease: HIV, HCV, HBV, HTLV and presence of irreversible communicable infectious diseases;
- Carrying of human Papilloma Virus High Risk (hPV-HR) class 1 positive in the genital tract if known before transplantation;
- Positive EBV (Epstein-Barr Virus) serology in the donor if the recipient is EBV negative for EBV ;
- Positive pre-transplant virtual crossmatch;
- Donor/recipient ABO final check in the operating room before transplantation positive;
- Drug addiction or alcoholism not weaned for more than 2 years or drug addiction or excessive alcohol consumption (> 30 g/day of alcohol) current;
- History of cancer less than 5 years old, cancer under treatment (except in the cancer in situ, or basal cell skin lesion) ;
- Active tuberculosis (i.e. under treatment);
- History of smoking (defined as consumption greater than 20 packs/year) not weaned for more than 2 years or active smoker.
- Non-stable psychological state defined by a clinical psychologist clinician after a qualitative interview;
- Severe co-morbidity;
- Diabetes (HbA1c > 6%);
- Hemostasis disorders: Prothrombin rate <70%;
- Hemoglobin abnormality;
- hypertension treated with more than 2 antihypertensive drugs;
- Delivery less than 6 months ago or ongoing pregnancy;
- History of cervical pathology;
- History of recurrent miscarriage syndrome (defined as 3 consecutive consecutive miscarriages);
- History of premature delivery before 36 weeks of amenorrhea;
- History of pre-eclampsia;
- History of caesarean sections;
- History of major uterine surgery;
- History of major abdominal or pelvic surgery;
- Endometrial biopsy and diagnostic hysteroscopy showing an abnormality of the endometrium;
- Known thrombophilia (acquired or constitutional);
- HIV, HCV, HBV, HTLV serology positive and presence of irreversible communicable infectious diseases;
- Positive vaginal hPV-HR (human Papilloma Virus High Risk) test;
- PCR (Polymerase Chain reaction) on HSV (Herpes Simplex Virus) 1/2 positive sample;
- Abnormal vaginal swab;
- Signs of chronic kidney disease;
- Risks of Prion disease transmission;
- Drug addiction or alcoholism not weaned for more than 2 years or drug addiction or excessive alcohol consumption (> 30 g/day of alcohol) current;
- History of cancer less than 10 years old, cancer under treatment (except in the cancer in situ, or basal cell skin lesion) or diagnosed during the selection process;
- History of pelvic radiotherapy or vaginal brachytherapy regardless of when this irradiation was performed;
- Known psychiatric pathology;
- Active tuberculosis (i.e. under treatment);
- Presence of a known thromboembolic risk factor;
- Angio-MRI, CT angiography and/or arteriography revealing an anomaly incompatible with uterine transplantation;
- History of smoking (defined as consumption greater than 20 packs/year) not weaned for more than 2 years or active smoker.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ludivine DION contact
France1 site, 1 recruiting
- Recruiting
Vincent LAVOUE
Rennes
Vincent LAVOUE, 299265971 ext. +33, vincent.lavoue@chu-rennes.fr
Ludivine DION, ludivine.dion@chu-rennes.fr
About this study
Patients with absolute Uterine Factor Infertility (AUFI) are infertile due to the absence of a uterus. The absence of a uterus can be either iatrogenic (hysterectomy for gynecological pathology such as cancer or for obstetric pathology such as postpartum hemorrhage with hysterectomy for hemostasis), or congenital with utero-vaginal agenesis including Mayer Rokitansky Küster Hauser syndrome (MRKH) is the most common syndrome of uterine agenesis.
Alongside the AUFI, there is Non-Absolute Uterine Factor Infertility (NAUFI) which corresponds to patients with a uterus in place but which is altered by different pathologies, most often acquired, making it unsuitable for embryonic implantation and preventing the patient to get pregnant.
Read more
Uterus Transplantation (UT) represents an interesting alternative to the treatment of AUFI and potentially NAUFI (in the event of a uterus present but unsuitable for implantation) to access parenthood, especially since it is the only proposal that allows the patient to be both the surrogate mother, the biological mother (in case of simple donation) and the legal mother.
Many animal experiments have been accelerated since the beginning of the 21st century demonstrating that uterus transplantation was technically feasible and that pregnancy was possible.
In humans, several teams have recently performed several uterus transplants and have shown that this procedure is possible whether the donor is alive or dead (state of brain death).
In France, two teams (Foch and Limoges) have developed a uterus transplantation program. One in the context of living donors and the other of a deceased donors.
At the University Hospital of Rennes, we want to offer a UT program allowing access to a living or deceased donor for women with AUFI (type 1 or 2 MRKH syndrome and hysterectomy).
Read the detailed description
Methods: Sixteen UT will be performed in total in 2 parallel arms: 8 UT from a live donor and 8 UT from a deceased brain-dead donor. Patients who have no suitable live donor will be wait-listed for a deceased donor.
Phases of the UT procedure: selection, in vitro fertilization and cryopreservation of embryos, uterus retrieval from a live donor or from a deceased donor, orthotopic uterus transplantation , follow up period (12 months), embryo transfer, pregnancy, child birth via Cesarian section (2 children maximum), later graft hysterectomy.
- Conditions
- Uterine Factor Infertility
- Being tested
- Live donor uterus transplantation, Deceased donor uterus transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live donor uterus transplantationProcedure or surgery
Transplantation of uterus from a living donor.
Deceased donor uterus transplantationProcedure or surgery
Transplantation of uterus from a deceased brain-dead donor.
| Study group | Role | What they receive |
|---|---|---|
| Live donor uterus transplantation | Experimental | Transplantation of uterus from a living donor. Immunosuppression with tacrolimus. Receives: Procedure: Live donor uterus transplantation |
| Deceased donor uterus transplantation | Experimental | Transplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus. Receives: Procedure: Deceased donor uterus transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of uterus transplantation
Show a functional uterus validated by the onset of menstruation and maintenance of menstruation 6 months after the uterine transplant has been performed
Measured: 6 months after uterus transplantation
Security of uterus transplantation
The number of living children resulting from uterine transplantation relative to the number of recorded complications defined by grade 3 complications of Clavien Dindo (complications of uterine transplant surgery in the post-operative month) and non-reversible complications of immunosuppressants (such as sequelae hypertension, blood disease, etc.).
Measured: Throughout the UT program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start23 Jan 2024
- Primary completionDec 2037 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Factor InfertilityStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Living donor versus deceased donor
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent LAVOUE, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726305
- Sponsor's protocol ID
- 35RC20_9902_TULIPE
- Acronym
- TULIPE
- Status last verified
- May 2025
- First submitted
- 3 Feb 2023
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Uterus for Uterine infertiLIty From Living Donor or Deceased Donor
- ClinicalTrials.gov ID
- NCT05726305
- Acronym / sponsor ID
- TULIPE / 35RC20_9902_TULIPE
- Conditions
- Uterine Factor Infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- Dec 2037 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 13 Feb 2023 (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.
Patients with absolute Uterine Factor Infertility (AUFI) are infertile due to the absence of a uterus. The absence of a uterus can be either iatrogenic (hysterectomy for gynecological pathology such as cancer or for obstetric pathology such as postpartum hemorrhage with hysterectomy for hemostasis), or congenital with utero-vaginal agenesis including Mayer Rokitansky Küster Hauser syndrome (MRKH) is the most common syndrome of uterine agenesis.
Alongside the AUFI, there is Non-Absolute Uterine Factor Infertility (NAUFI) which corresponds to patients with a uterus in place but which is altered by different pathologies, most often acquired, making it unsuitable for embryonic implantation and preventing the patient to get pregnant.
Uterus Transplantation (UT) represents an interesting alternative to the treatment of AUFI and potentially NAUFI (in the event of a uterus present but unsuitable for implantation) to access parenthood, especially since it is the only proposal that allows the patient to be both the surrogate mother, the biological mother (in case of simple donation) and the legal mother.
Many animal experiments have been accelerated since the beginning of the 21st century demonstrating that uterus transplantation was technically feasible and that pregnancy was possible.
In humans, several teams have recently performed several uterus transplants and have shown that this procedure is possible whether the donor is alive or dead (state of brain death).
In France, two teams (Foch and Limoges) have developed a uterus transplantation program. One in the context of living donors and the other of a deceased donors.
At the University Hospital of Rennes, we want to offer a UT program allowing access to a living or deceased donor for women with AUFI (type 1 or 2 MRKH syndrome and hysterectomy).
Detailed description
Methods: Sixteen UT will be performed in total in 2 parallel arms: 8 UT from a live donor and 8 UT from a deceased brain-dead donor. Patients who have no suitable live donor will be wait-listed for a deceased donor.
Phases of the UT procedure: selection, in vitro fertilization and cryopreservation of embryos, uterus retrieval from a live donor or from a deceased donor, orthotopic uterus transplantation , follow up period (12 months), embryo transfer, pregnancy, child birth via Cesarian section (2 children maximum), later graft hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Living donor versus deceased donor
| Arm | Type | Receives |
|---|---|---|
| Live donor uterus transplantation | Experimental | Procedure: Live donor uterus transplantationTransplantation of uterus from a living donor. Immunosuppression with tacrolimus. |
| Deceased donor uterus transplantation | Experimental | Procedure: Deceased donor uterus transplantationTransplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient aged 18 to 40 at the time of the UT;
- BMI (Body Mass Index) ≤ 30 kg/m²;
- With AUFI (type 1 or 2 MRKH syndrome and hysterectomy);
- Informed about the possibility of adoption;
- Compatibility with the donor (ABO group, Human Leukocyte Antigen (HLA) typing);
Key exclusion criteria (74 listed)
- Patient with acquired uterine infertility and having had one or more children;
- Non-stable psychological state defined by a clinical psychologist after a qualitative interview;
- Severe co-morbidity;
- Association of severe abnormality with MRKH syndrome other than renal such as a cardiac malformation;
- A single pelvic kidney (urinary malformation that can be associated with MRKH syndrome);
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 |
|---|---|---|
| Live donor uterus transplantationTransplantation of uterus from a living donor. | Procedure or surgery | Live donor uterus transplantation |
| Deceased donor uterus transplantationTransplantation of uterus from a deceased brain-dead donor. | Procedure or surgery | Deceased donor uterus transplantation |
Primary outcome
Efficacy of uterus transplantation
Time frame: 6 months after uterus transplantation
Show a functional uterus validated by the onset of menstruation and maintenance of menstruation 6 months after the uterine transplant has been performed
Security of uterus transplantation
Time frame: Throughout the UT program
The number of living children resulting from uterine transplantation relative to the number of recorded complications defined by grade 3 complications of Clavien Dindo (complications of uterine transplant surgery in the post-operative month) and non-reversible complications of immunosuppressants (such as sequelae hypertension, blood disease, etc.).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
Related trials for Uterine Factor Infertility
Active, not recruiting
The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial
Mayer Rokitansky Kuster Hauser Syndrome, Uterine Agenesis
RecruitingPhase 2/3
Uterus Transplantation to Treat Infertility
Uterine Factor Infertility
Recruiting
Uterine Transplant for Women With Absolute Uterine Factor Infertility (AUFI)
Mayer Rokitansky Kuster Hauser Syndrome, Absence of Uterus
Active, not recruiting
Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility
Absolute Uterine Infertility
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Uterine Transplantation for the Treatment of Uterine Factor Infertility
Primary Uterine Infertility
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.
Ludivine DION contact
Vincent LAVOUE principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live donor uterus transplantation and Deceased donor uterus transplantation in people with Uterine Factor Infertility, run by Rennes University Hospital at 1 site in France.
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 18 inclusion and 74 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent LAVOUE (299265971 ext. +33, vincent.lavoue@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of uterus transplantation (time frame: 6 months after uterus transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2025.