The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial

NCT03307356 | Active Not Recruiting DMC

• 1 other identifier: 827853
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Options for childbearing are limited for the thousands of women in the United States who suffer from absolute uterine factor infertility. Uterine transplantation is an emerging treatment that provides hope for these individuals. In the Penn UNTIL trial, the investigators plan to perform uterus transplants on five women who will ultimately undergo embryo transfer, pregnancy, delivery, and then transplant hysterectomy. This trial is accepting women in need of a transplant and also women who are interested in being a live donor. For more information please visit: https://clinicalresearch.itmat.upenn.edu/clinicaltrial/4821/congenital-abnormalitiesfemale-infertility-penn-ut/

Conditions

Mayer Rokitansky Kuster Hauser Syndrome; Uterine Agenesis; Infertility, Female, of Uterine Origin; Uterine Factor Infertility

Keywords

Uterine Transplant; MRKH

Outcome Measures

Primary Outcomes (3)

• Recipient: Successful engraftment of deceased or living donor uterus

  Uterus remains in recipient with no complications (i.e. infection or rejection) or any complications that did arise could be successfully treated.

  Assessed 6 months after transplant

• Recipient: Live-born child per embryo transfer

  Assessed up to 35 weeks post-embryo transfer

• Living Donor: Survival post-donation

  Living or deceased

  Assessed at 2 years post-hysterectomy

Secondary Outcomes (10)

• Recipient: Neonatal growth

  Assessed at birth

• Recipient: Pregnancy complications

  Assessed up to 35 weeks post-embryo transfer

• Recipient: Surgical or medical complications following cesarean delivery

  Assessed up to 6 months after delivery

• Recipient: Surgical or medical complications following hysterectomy

  Assessed 2 years after hysterectomy

• Recipient: Child height percentile

  Assessed at 2 years

Study Arms (1)

Uterine Transplantation

EXPERIMENTAL

Women will undergo extensive medical and psychological screening. Five women that meet all inclusion and exclusion criteria will undergo ovarian stimulation, oocyte retrieval and will create embryos that will be stored for future use. Women will then undergo uterine transplantation from a donor. Following transplant women will be closely monitored for complications (including infection and rejection). If no complications arise, or complications that do arise can be treated, attempts at pregnancy will begin approximately 6 months after transplant. Pregnancy in the setting of uterine transplant requires directly placing embryos directly into the uterus.

Other: Uterine Transplant

Interventions

Uterine Transplant OTHER

Transplant of a uterus from a donor, deceased or living

Also known as: Donor Uterine Transplant

Uterine Transplantation

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Female sex; specifically XX-bearing individual
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• XX-bearing individual diagnosed with Uterine Factor Infertility (UFI) a
• Age 21-40
• Lives in Philadelphia region for the duration of the trial
• Received counseling regarding alternatives to uterine transplant such as adoption or surrogacy
• Intact ovaries
• Vaginal length \>6 cm (average vaginal length established with dilators)
• Body mass index \<35 kg/m2
• Fluent in the English Language
• If cervix present/previously present, human papillomavirus (HPV)) negative or received vaccination for HPV
• Willing to comply with screening, protocol and all required procedures
• Has adequate social support
• Has undergone controlled ovarian hyperstimulation, egg retrieval, in vitro fertilization, and embryo freezing and has frozen embryos of sufficient embryo quality/quantity (≥2 high quality blastocysts); (Required for Transplant Phase, not Screening or Evaluation Phases)

You may not qualify if:

• Previous multiple major abdominal/pelvic surgery
• Severe endometriosis
• History of hypertension, diabetes mellitus, thrombophilia or other clotting or bleeding disorders, significant heart, liver, kidney or central nervous system disease
• History of prior malignancy except for cervical cancer in stage 1a or 1b (must be in remission for 3 years)
• History of significant psychiatric illness
• Allergy, hypersensitivity, or intolerance of expected immunosuppressive agents (i.e. Thymoglobulin®, tacrolimus, etc.)
• Allergy, hypersensitivity, or intolerance of heparin or aspirin
• Presence of active documented systemic infection or recent systemic infection within the past 3 months
• Seropositivity for HIV, HBV core antibody or antigen, HCV
• Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
• Chemical and/or alcohol dependency or abuse
• Psychosocial problems (including alcoholism, drug abuse, documented behavioral disorders)
• Renal abnormalities, specifically single kidney or pelvic kidneys (imaging confirmation of 2 normal kidneys is required for MRKH subjects)
• Contraindications to pregnancy
• Unwilling to receive a transfusion of blood or blood products

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (14)

• Griffin JE, Edwards C, Madden JD, Harrod MJ, Wilson JD. Congenital absence of the vagina. The Mayer-Rokitansky-Kuster-Hauser syndrome. Ann Intern Med. 1976 Aug;85(2):224-36. doi: 10.7326/0003-4819-85-2-224.

  PMID: 782313 BACKGROUND

• White PM. "One for Sorrow, Two for Joy?": American embryo transfer guideline recommendations, practices, and outcomes for gestational surrogate patients. J Assist Reprod Genet. 2017 Apr;34(4):431-443. doi: 10.1007/s10815-017-0885-7. Epub 2017 Feb 9.

  PMID: 28185120 BACKGROUND

• Ethics Committee of the American Society for Reproductive Medicine. Consideration of the gestational carrier: a committee opinion. Fertil Steril. 2013 Jun;99(7):1838-41. doi: 10.1016/j.fertnstert.2013.02.042. Epub 2013 Mar 29.

  PMID: 23541404 BACKGROUND

• Drabiak K, Wegner C, Fredland V, Helft PR. Ethics, law, and commercial surrogacy: a call for uniformity. J Law Med Ethics. 2007 Summer;35(2):300-9. doi: 10.1111/j.1748-720X.2007.00139.x.

  PMID: 17518856 BACKGROUND

• O'Leary JA, Feldman M, Gaensslen DM. Uterine and tubal transplantation. Fertil Steril. 1969 Sep-Oct;20(5):757-60. doi: 10.1016/s0015-0282(16)37148-5. No abstract available.

  PMID: 5822860 BACKGROUND

• Brannstrom M, Bokstrom H, Dahm-Kahler P, Diaz-Garcia C, Ekberg J, Enskog A, Hagberg H, Johannesson L, Kvarnstrom N, Molne J, Olausson M, Olofsson JI, Rodriguez-Wallberg K. One uterus bridging three generations: first live birth after mother-to-daughter uterus transplantation. Fertil Steril. 2016 Aug;106(2):261-6. doi: 10.1016/j.fertnstert.2016.04.001. Epub 2016 Apr 25.

  PMID: 27125227 RESULT

• Nair A, Stega J, Smith JR, Del Priore G. Uterus transplant: evidence and ethics. Ann N Y Acad Sci. 2008 Apr;1127:83-91. doi: 10.1196/annals.1434.003.

  PMID: 18443334 RESULT

• McKay DB, Josephson MA. Pregnancy in recipients of solid organs--effects on mother and child. N Engl J Med. 2006 Mar 23;354(12):1281-93. doi: 10.1056/NEJMra050431. No abstract available.

  PMID: 16554530 RESULT

• Saso S, Clarke A, Bracewell-Milnes T, Saso A, Al-Memar M, Thum MY, Yazbek J, Del Priore G, Hardiman P, Ghaem-Maghami S, Smith JR. Psychological Issues Associated With Absolute Uterine Factor Infertility and Attitudes of Patients Toward Uterine Transplantation. Prog Transplant. 2016 Mar;26(1):28-39. doi: 10.1177/1526924816634840.

  PMID: 27136247 RESULT

• Brannstrom M. Uterus transplantation and beyond. J Mater Sci Mater Med. 2017 May;28(5):70. doi: 10.1007/s10856-017-5872-0. Epub 2017 Mar 29.

  PMID: 28357688 RESULT

• Flyckt RL, Farrell RM, Perni UC, Tzakis AG, Falcone T. Deceased Donor Uterine Transplantation: Innovation and Adaptation. Obstet Gynecol. 2016 Oct;128(4):837-842. doi: 10.1097/AOG.0000000000001617.

  PMID: 27607877 RESULT

• Testa G, Koon EC, Johannesson L, McKenna GJ, Anthony T, Klintmalm GB, Gunby RT, Warren AM, Putman JM, dePrisco G, Mitchell JM, Wallis K, Olausson M. Living Donor Uterus Transplantation: A Single Center's Observations and Lessons Learned From Early Setbacks to Technical Success. Am J Transplant. 2017 Nov;17(11):2901-2910. doi: 10.1111/ajt.14326. Epub 2017 May 23.

  PMID: 28432742 RESULT

• Johannesson L, Humphries LA, Porrett PM, Testa G, Anderson S, Walter JR, Rush M, Ferrando CA, O'Neill K, Richards EG. Classification and treatment of vaginal strictures at the donor-recipient anastomosis after uterus transplant. Fertil Steril. 2024 Sep;122(3):525-534. doi: 10.1016/j.fertnstert.2024.04.019. Epub 2024 Apr 16.

  PMID: 38636770 DERIVED

• Walter JR, Johannesson L, Falcone T, Putnam JM, Testa G, Richards EG, O'Neill KE. In vitro fertilization practice in patients with absolute uterine factor undergoing uterus transplant in the United States. Fertil Steril. 2024 Sep;122(3):397-405. doi: 10.1016/j.fertnstert.2024.04.017. Epub 2024 Apr 15.

  PMID: 38631504 DERIVED

Related Links

• Please visit the UPENN Study Web Page

MeSH Terms

Conditions

Mullerian aplasia; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Kathleen E O'Neill, MD, MTR

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 11, 2017
• Study Start: January 10, 2018
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

US (1)