Objective
Until the first birth from uterine transplantation reported in 2015, uterine factor infertility (UFI) was considered an incurable diagnosis. UFI can result from congenital causes, such as Mayer-Rokitansky-Küster-Hauser syndrome, or acquired causes, such as hysterectomy. This novel surgical approach may provide women who are affected by UFI with an opportunity to carry their own biologic child when adoption, foster care, or gestational surrogacy are either not available or not desirable. After the initial promising results of the Swedish clinical trial, interest in human uterine transplantation worldwide has increased. Our team recently published our own practical experience in designing and implementing the first human uterine transplant clinical trial in the United States, which included a discussion of the ethical considerations relevant to this undertaking. The objective of this study is to describe the characteristics of women with UFI who were screened for our clinical trial. These data may provide important insights into women who are contemplating uterine transplantation protocols.
Study Design
Our clinical trial was approved by the Institutional Review Board at the Cleveland Clinic in September 2015. This research protocol is funded internally to perform 10 deceased donor uterine transplants in women with UFI. The applicants described here independently contacted our institution regarding the protocol; there was no advertising or recruiting for our clinical trial aside from the listing on Clinicaltrials.gov (identifier: NCT02573415 ). In this study, we report demographic data and descriptive characteristics of our screened candidates.
Study Design
Our clinical trial was approved by the Institutional Review Board at the Cleveland Clinic in September 2015. This research protocol is funded internally to perform 10 deceased donor uterine transplants in women with UFI. The applicants described here independently contacted our institution regarding the protocol; there was no advertising or recruiting for our clinical trial aside from the listing on Clinicaltrials.gov (identifier: NCT02573415 ). In this study, we report demographic data and descriptive characteristics of our screened candidates.
Results
Over 250 reproductiveaged candidates contacted our institution to obtain further information. Of these, 239 candidates were included for initial screening over 7 months. The mean age of the women who were screened was 31 years (range: 18–52 years), with younger applicants (mean age: 28 years) in the Mayer-Rokitansky-Küster-Hauser syndrome group versus the acquired UFI group (mean age: 33 years). Moreover, women with congenital UFI represented only one-third of the population (32%, n=78) versus women with UFI secondary to previous hysterectomy (64%, n=154). Among those women with secondary causes of UFI ( Table ), the primary indications were benign conditions (50.0%) followed by gynecologic malignancies (25.3%) and obstetric complications (24.7%). Ninety-four percent of the applicants lived within the United States. Although most of the women screened did not indicate a specific religion, of the 26 patients who did note a religious affiliation, 19 were Christian, 2 were Muslim, and the rest were of other religious backgrounds. Sixty-seven percent of candidates were Caucasian. 93% of the screened women were legally married or in a stable relationship, and 7% of them were single. Our protocol allows for sperm donation in the context of women without a partner or women in a same-sex relationship. Seventeen percent of the screened candidates had at least 1 child already. Of note, there were 5 male-to-female transgender applicants (2%) and 1 applicant with an intersex diagnosis. These applicants were excluded based on current inclusion/exclusion criteria.
