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Uterine Transplant for Infertility
Study Summary
This trial is for a new form of transplant to treat Absolute Uterine Factor Infertility (AUFI). The technique of uterus transplant was developed in Sweden and this trial will be performed in the United States. The transplant is of a uterus from a living or deceased donor to a woman affected by AUFI.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I either don't have herpes simplex virus type 2 (HSV-2) or have it without current symptoms.You have smoked tobacco within the past 6 months.I have been informed about fertility options including adoption and surrogacy.I have tested negative for Gonorrhea, Chlamydia, Syphilis, and do not have active bacterial vaginosis or a yeast infection.I am willing to undergo IVF to secure 4 viable embryos for transplant.I am a woman with AUFI and have at least one working ovary.I cannot have in-vitro fertilization or am not approved for a transplant.You have abused drugs or alcohol within the past year before the screening.I have high blood pressure or other health issues that make the procedure risky for me.I am a woman with AUFI but have at least one working ovary.You have been assessed by a fertility specialist who confirmed that you have healthy eggs and the ability to have children.I have had a solid organ or bone marrow transplant, or I have a history of cancer.I am a woman aged 20-40 and biologically female.I have diabetes or my blood sugar levels are high.I am allergic to Tacrolimus, Thymoglobulin, or Everolimus.I am willing to fill out questionnaires about my baby's growth and development.I currently have an active infection, such as candida or bacterial vaginosis.I do not have active HPV or cervical dysplasia.I do not have active HPV or cervical dysplasia.My BMI is over 30.I either do not have HSV-2 or have had it without current symptoms.I have body structures that make surgery very risky.I am willing and able to follow the study's requirements.I agree to have a hysterectomy if I leave the study with the transplanted uterus still in.I am a woman aged 20-40 and have the XX chromosome.You have a body mass index (BMI) of over 30, which means you are considered obese.You meet the psychological requirements to participate in the study.
- Group 1: Uterine Transplant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the elderly demographic being included in this trial?
"Patients aged 20-65 are suitable to participate in this medical trial, though there are additional trials for those younger or older than the specified range. 14 studies cater to minors and 35 focus on elderly participants."
Do I fulfill the qualifications for participation in this clinical experiment?
"For this trial, 10 female patients between 20 and 65 years old with a functioning uterus are required. Moreover, it is essential that participants meet the following criteria: Positive test results for Gonorrhea Chlamydia and Syphilis; no active bacterial vaginosis or candida infection (previously treated STDs allowed); absence of HPV or cervical dysplasia; HSV-2 negative status or past history without current symptoms; informed consent regarding all fertility options such as surrogate pregnancy and adoption before enrolling in the study; assessment by a fertility specialist to ensure good ovarian reserve and reproductive potential; agreement to undergo hysterectomy in"
Is this scientific investigation available to participants at the present time?
"Evidenced by clinicaltrials.gov, this medical trial is currently open for recruitment. It was initiated on June 3rd 2022 and the most recent alteration to its information took place on June 21st 2022."
What is the extent of the population being evaluated in this experiment?
"Affirmative, the information available on clinicaltrials.gov asserts that this research project is currently accepting participants. This medical study was first posted on June 3rd 2022 and its most recent update occurred on June 21st 2022. Enrolment for this trial demands 10 patients from one site."
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