Houston, TXNCT05263076Now EnrollingIRB Ready

Mayer Rokitansky Kuster Hauser Syndrome Clinical Trial in Houston, TX

Access cutting-edge mayer rokitansky kuster hauser syndrome treatment through this clinical trial at a research site in Houston. Study-provided care at no cost to qualified participants.

Sponsored by John Goss

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related mayer rokitansky kuster hauser syndrome treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Houston

    Convenient for TX residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Houston site if eligible
  4. 4Begin participation

About This Mayer Rokitansky Kuster Hauser Syndrome Study in Houston

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. Uterine transplant is a new form of transplant to treat AUFI. The technique of uterus transplant was developed in Sweden with the transplantation of the uterus from a living donor to a woman affected by AUFI. Approximately 80 uterine transplantations have been performed, more than 50 of which have occurred within the past 3 years. To date, 34 children have been born from mothers who have received a living donor uterine transplant. This is a prospective study to treat Absolute Uterine Factor Infertility (AUFI) through uterine transplantation utilizing a uterus from a living or deceased donor resulting in live birth. A total of 10 biologically female (XX Karyotype) subjects will receive a uterine transplant.

Sponsor: John Goss

Who Can Participate

Inclusion Criteria

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).
Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
Subjects will have negative testing for Gonorrhea Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (Subjects with previously treated STDs will be included if the infection is no longer present and has no impact. If a subject develops an STD/infection pre-operatively, she will be treated and monitored for a period of 3 months until she is no longer affected. She will then become eligible for transplant. If a subject develops an STD/infection after transplant/during pregnancy she will be treated appropriately. Prior to the embryo transfer the patient will be tested and treated if necessary. Any patient with an active STD/infection will be ineligible for any elective procedure until she is tested and treated appropriately.)
Subjects who are HSV-2 negative or who have a history of HSV-2 with no current symptoms. Subjects may require preventative maintenance per study doctor discretion.
Subjects have received counseling regarding all fertility options and alternatives to uterine transplant such as adoption or surrogate pregnancy.
Subjects 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.
Subjects have been evaluated by a fertility specialist and determined to have good ovarian reserve and reproductive potential.
Subjects 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 hysterectomy for her own safety.
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

Exclusion Criteria

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 Type 2 is associated with skeletal/spinal and renal anomalies, making them higher risk candidates. DONOR INCLUSION CRITERIA
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.
Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
Subjects will have negative testing for Gonorrhea, Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (Subjects with previously treated STDs will be included if the infection is no longer present and has no impact. If a subject develops an STD/infection pre-operatively, she will be treated and monitored for a period of 3 months until she is no longer affected. Any patient with an active STD/infection will be ineligible for any elective procedure until she is tested and treated appropriately.)
Subjects who are HSV-2 negative, or have a history of HSV-2 but with no current symptoms. Subjects may require preventative maintenance per study doctor discretion.
Subjects will have a normal uterus on sonogram and CT.
Subjects will have normal psychological donor criteria (if living).
Subjects 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT05263076) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mayer Rokitansky Kuster Hauser Syndrome Treatment Options in Houston, TX

If you're searching for mayer rokitansky kuster hauser syndrome treatment options in Houston, TX, this clinical trial (NCT05263076) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mayer rokitansky kuster hauser syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mayer rokitansky kuster hauser syndrome clinical trials near you to find additional studies recruiting in your area.

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