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New treatment option for Mayer Rokitansky Kuster Hauser Syndrome
Official title Uterine Transplant for Women With Absolute Uterine Factor Infertility (AUFI)
ClinicalTrials.gov ID: NCT05263076
What this study is testing
- What it's testing
- Absolute Uterine Factor Infertility (AUFI) is due to congenital or surgical absence of a uterus or the presence of a nonfunctional uterus. Until 2014, the only option for women affected by Absolute Uterine Factor Infertility (AUFI) was adoption or surrogate motherhood.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 65, women only
You may be able to join if
- RECIPIENT 1. Women who are diagnosed with Absolute Uterine Factor Infertility (AUFI) and who have at least one functioning ovary.
- Women of childbearing age (20-40 years old) who are biologically female (XX karyotype).
- people will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
- people will have negative testing for Gonorrhea Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (people...
- people who are HSV-2 negative or who have a history of HSV-2 with no current symptoms. people may require preventative maintenance per study doctor...
You likely can't join if
- Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test.
- Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or Everolimus.
- Subject with a diagnosis of hypertension, or any other significant medical condition that makes this procedure unsafe or is a contraindication to...
- Subject who has a history of solid organ or bone marrow transplant, per investigator's discretion.
- Subject who has a history of cancer, per investigator's discretion.
- Subject with a body mass index \>30.
See the full eligibility criteria
Who can join
- RECIPIENT 1. Women who are diagnosed with Absolute Uterine Factor Infertility (AUFI) and who have at least one functioning ovary.
- Women of childbearing age (20-40 years old) who are biologically female (XX karyotype).
- people will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
- people will have negative testing for Gonorrhea Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (people with previously treated STDs will be included if the infection is no...
- people who are HSV-2 negative or who have a history of HSV-2 with no current symptoms. people may require preventative maintenance per study doctor discretion.
- people have received counseling regarding all fertility options and alternatives to uterine transplant such as adoption or surrogate pregnancy.
- people are willing to undergo in-vitro fertilization to obtain the necessary 4 viable embryos required for eligibility for transplant if they have not already banked 4 viable embryos.
- people have been evaluated by a fertility specialist and determined to have good ovarian reserve and reproductive potential.
- people must agree that in the event of withdrawal from the study while the transplanted uterus is in place, unless she is enrolled in an equivalent uterine transplant program, she will be required to undergo a...
- Subject meets psychological recipient criteria.
- Subject must be willing to complete questionnaires about their infant's growth and development and return them to the study team. RECIPIENT
What rules you out
- Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test.
- Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or Everolimus.
- Subject with a diagnosis of hypertension, or any other significant medical condition that makes this procedure unsafe or is a contraindication to surgery or anesthesia.
- Subject who has a history of solid organ or bone marrow transplant, per investigator's discretion.
- Subject who has a history of cancer, per investigator's discretion.
- Subject with a body mass index \>30.
- Subject with an active infection including candida and/or bacterial vaginosis.
- Subject who is seropositive for HIV, HBV, HCV.
- Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator.
- Subject unwilling or unable to comply with study requirements.
- Subject unable to undergo in-vitro fertilization or not cleared for transplant.
- Subject who has smoked within the last 6 months.
- Subject who has alcohol or drug abuse within 12 months of screening.
- Subject with any pre-existing clinical or medical conditions that would put the subject at an increased risk. Of note, for Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome, the investigators will favor Type 1 variants as...
- Women must be between 25-65 years of age. If a subject is less than 40 years old she must be certain that she does not wish to carry more children, and she will attest to this decision.
- people will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
- people will have negative testing for Gonorrhea, Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (people with previously treated STDs will be included if the infection is no...
- people who are HSV-2 negative, or have a history of HSV-2 but with no current symptoms. people may require preventative maintenance per study doctor discretion.
- people will have a normal uterus on sonogram and CT.
- people will have normal psychological donor criteria (if living).
- people will have had at least one prior full term live birth. DONOR EXCLUSION CRITERIA
- Donor over the age of 65.
- Body mass index \>30.
- Subject with an active infection including candida and/or bacterial vaginosis.
- Subject who is seropositive for HIV, HBV, HCV
- Subject who has had cancer in the last five years.
- Subject with any pre-existing clinical or medical condition that would place the subject at an increased risk or would be a contraindication to surgery or anesthesia.
- Subject who has smoked within the last 6 months.
- Subject who has alcohol or drug abuse within 12 months of screening.
- Subject unwilling or unable to comply with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.