What is the mechanism of action of this treatment?

Uterine Agenesis, a form of Absolute Uterine Factor Infertility (AUFI), can be treated through uterine transplantation, where a uterus from a living or deceased donor is transplanted into the patient. This procedure allows women who were born without a functional uterus to achieve pregnancy and carry a child to term. The mechanism involves surgically implanting the donor uterus into the recipient, followed by immunosuppressive therapy to prevent organ rejection. This treatment is significant for Uterine Agenesis patients as it provides an opportunity for biological motherhood, which was previously only possible through adoption or surrogacy.

What side effects are associated with this type of intervention?

Uterine transplants, used to treat Uterine Agenesis, can have several side effects. Surgical complications may include infection, bleeding, and thrombosis. Patients must take immunosuppressive medications to prevent organ rejection, which can increase the risk of infections, hypertension, and kidney damage. Additionally, pregnancies post-transplant carry risks such as preeclampsia and preterm birth.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Uterine Agenesis. The primary treatment being studied for Absolute Uterine Factor Infertility (AUFI), which includes Uterine Agenesis, is uterine transplantation. This procedure involves transplanting a uterus from a living or deceased donor to a woman affected by AUFI. This innovative approach has led to the birth of children from mothers who have received a uterine transplant, marking a significant advancement in treating this condition.

What other types of research exist?

Promising, novel alternatives to uterine transplant for Uterine Agenesis patients in 2024 include advancements in assisted reproductive technologies (ART) such as improved surrogacy options and potential future developments in bioengineered or 3D-printed uterine tissues. These alternatives aim to provide viable options for women with Absolute Uterine Factor Infertility (AUFI) without the need for a traditional uterine transplant.

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Procedure

Uterine Transplant for Infertility

N/A

Recruiting

Led By John Goss, M.D.

Research Sponsored by John Goss

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with negative testing for Gonorrhea, Chlamydia, and Syphilis, and without active bacterial vaginosis or candida infection

Women diagnosed with Absolute Uterine Factor Infertility (AUFI) and have at least one functioning ovary

Must not have

Subjects unable to undergo in-vitro fertilization or not cleared for transplant

Subjects with a diagnosis of hypertension or other significant medical conditions contraindicating the procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-operative

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help women by transplanting a donor uterus. These women cannot carry a pregnancy because their uterus is either missing or not working properly. The transplanted uterus allows them to try to become pregnant. This method has been successfully introduced as a treatment option for women with this condition.

Who is the study for?

This trial is for women aged 20-40 with Absolute Uterine Factor Infertility (AUFI) due to a missing or nonfunctional uterus, who have at least one working ovary and are willing to undergo in-vitro fertilization. They must not smoke, abuse substances, or have recent cancer history. Women over 65, those with significant health risks like diabetes or hypertension, and anyone unable to meet study requirements are excluded.

What is being tested?

The trial is testing uterine transplants from living or deceased donors as a treatment for AUFI in women who wish to give birth. The goal is successful pregnancy and live birth post-transplantation. Ten participants will receive transplants after ensuring they have viable embryos through IVF.

What are the potential side effects?

Potential side effects may include complications related to surgery such as infection risk, reaction to anesthesia, rejection of the transplanted uterus requiring removal (hysterectomy), and possible adverse reactions to immunosuppressive drugs used to prevent transplant rejection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tested negative for Gonorrhea, Chlamydia, Syphilis, and do not have active bacterial vaginosis or a yeast infection.

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I am a woman with AUFI and have at least one working ovary.

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I do not have active HPV or cervical dysplasia.

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I either do not have HSV-2 or have had it without current symptoms.

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I agree to have a hysterectomy if I leave the study with the transplanted uterus still in.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have in-vitro fertilization or am not approved for a transplant.

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I have high blood pressure or other health issues that make the procedure risky for me.

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I have had a solid organ or bone marrow transplant, or I have a history of cancer.

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I am allergic to Tacrolimus, Thymoglobulin, or Everolimus.

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I currently have an active infection, such as candida or bacterial vaginosis.

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My BMI is over 30.

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I have diabetes or my blood sugar levels are high.

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I have body structures that make surgery very risky.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants that have a score of II or less on the Clavian-Dindo Scale.

Number of participants that have successful procurement of a viable uterus for transplant.

Successful establishment of a pregnancy via in vitro fertilization

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Uterine TransplantExperimental Treatment1 Intervention

uterus transplantation from living or deceased donor.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Uterine Agenesis, a form of Absolute Uterine Factor Infertility (AUFI), can be treated through uterine transplantation, where a uterus from a living or deceased donor is transplanted into the patient. This procedure allows women who were born without a functional uterus to achieve pregnancy and carry a child to term. The mechanism involves surgically implanting the donor uterus into the recipient, followed by immunosuppressive therapy to prevent organ rejection. This treatment is significant for Uterine Agenesis patients as it provides an opportunity for biological motherhood, which was previously only possible through adoption or surrogacy.