Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy

NCT07419490 | Recruiting DMC

• 1 other identifier: STUDY008615
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a Phase I clinical trial enrolling female patients aged 18-40 years who have been diagnosed with pelvic malignancies requiring whole pelvic external radiation therapy (WPXRT) and who express interest in preserving fertility and ovarian function. The trial's primary objective is to assess the feasibility and safety of uterine and ovarian transposition (UOT). Premenopausal women under the age of 40 will undergo UOT using a novel minimally invasive approach. Feasibility and safety will be evaluated through standardized postoperative assessments, including: (A) success in mobilizing and repositioning the uterus, ovaries, and fallopian tubes while maintaining vascular integrity; (B) documentation of surgical complications; (C) monitoring the timeliness and adherence to planned WPXRT. To enhance safety and optimize outcomes, intraoperative imaging with indocyanine green fluorescence and Doppler ultrasonography will be employed. Short-term success will be defined by technical success in repositioning the uterus and ovaries with preserved vascular integrity, absence of major surgical complications, and timely initiation and completion of WPXRT. Long-term success will be evaluated by the preservation of fertility. The study's primary objective is also to evaluate surgical, reproductive, and quality-of-life outcomes following UOT. This objective will determine the procedure's efficacy in preserving ovarian and menstrual function and its potential to support future pregnancies. Endpoints include: (A) maintenance of normal premenopausal levels of FSH, LH, AMH, and estradiol at defined postoperative intervals; (B) assessment of menstrual timing, regularity, and characteristics to document return of ovulatory cycles; (C) evaluation of uterine integrity and reproductive potential using pelvic ultrasonography; (D) comprehensive evaluation of patient quality of life encompassing physical, emotional, sexual, and reproductive well-being. These measures will inform optimization of surgical techniques and provide a foundation for scaling the procedure to a broader population in future studies.

Conditions

Colorectal (Colon or Rectal) Cancer; Pelvic Malignancies; Oncofertility

Keywords

uterine transposition; utero-ovarian transposition; oncofertility; pelvic radiation; pelvic malignancies; rectal cancer; colorectal malignancies; fertility preservation

Outcome Measures

Primary Outcomes (1)

• Success of uterine transposition

  Success of uterine transposition (feasibility) will be defined as the percentage of cases in which the uterus, ovaries, and fallopian tubes are successfully mobilized and repositioned as planned without the need for intraoperative conversion. Unit of Measure: Percentage of participants (%) Time Frame: up 30 days postsurgery.

  From enrollment to completion of surveillance/monitoring at 52 weeks

Secondary Outcomes (8)

• Postoperative Complications

  From enrollment to 4 weeks postsurgery

• Menstrual Function

  From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery

• Hormonal Function: Follicle-Stimulating Hormone (FSH)

  From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery

• Hormonal Function: Luteinizing Hormone (LH)

  From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery

• Hormonal Function: Anti-Mullerian Hormone (AMH)

  From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery

Study Arms (1)

Uteroovarian transposition arm

EXPERIMENTAL

Our study population includes premenopausal women 18-40 years old who are diagnosed with pelvic malignancies, such as rectal, colorectal cancer, and other pelvic malignancies that require radiotherapy and wish to preserve fertility and ovarian function. Subjects will be interested in improving their quality of life and reproductive outcomes without the need to undergo additional reproductive endocrinology interventions. Eligible patients will undergo UOT using a novel minimally invasive approach.

Procedure: Uteroovarian transposition

Interventions

Uteroovarian transposition PROCEDURE

Uteroovarian transposition involves temporarily relocating the uterus, both ovaries and fallopian tubes outside the planned radiation field. Once WPXRT is complete, a second surgery is performed to return these organs to their natural position in the patient's pelvis.

Also known as: uterine transposition

Uteroovarian transposition arm

Eligibility Criteria

• Age: 18 Months - 40 Months
• Gender Eligibility Details: Premenopausal women with uterus and ovaries in place
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: Women 18 - 40 years of age who wish to preserve their fertility.
• Malignancy: Diagnosis of pelvic malignancies that require radiotherapy, including:
• Colon and rectal cancer with tumors.
• Anal cancer.
• Other pelvic malignancies that require administration of WPXRT.
• Desire for Fertility Preservation: The patient expresses a clear desire to preserve fertility and the ability to carry a pregnancy in the future.
• Preoperative Ovarian Function: The patient must have normal ovarian function, demonstrated by specific hormonal values, including:
• Follicle-Stimulating Hormone (FSH): \<10 IU/L
• Luteinizing Hormone (LH): within normal reference range for reproductive age (typically 1.5-8 IU/L in the early follicular phase).
• Anti-Müllerian Hormone (AMH): \>1 ng/mL
• Estradiol (E2): within the normal range for the follicular phase (usually 30-120 pg/mL).
• No Distant Metastasis: Absence of metastatic disease confirmed by imaging (CT, MRI, or PET scans).
• Body Mass Index (BMI) \< 35.
• Signed Informed Consent.

You may not qualify if:

• Advanced Cancer Stage: Patients with locally advanced or metastatic disease.
• Significant Uterine Pathology: Presence of large uterine fibroids, adenomyosis, or other intrauterine pathologies that would complicate the procedure or future pregnancy.
• Poor General Health or Comorbidities: Severe medical conditions that contraindicate surgical intervention, that include but not limited to:
• Cardiovascular Disease:
• Recent (within 6 months) myocardial infarction (MI).
• Ejection fraction (EF): EF \<30%.
• Uncontrolled hypertension: Systolic BP \>180 mmHg or Diastolic BP \>110 mmHg prior to surgery.
• Severe aortic stenosis: Valve area \<1 cm² with symptomatic status.
• Uncontrolled Diabetes Mellitus:
• Hemoglobin A1c (HbA1c) \> 9%
• Persistent fasting glucose \>250 mg/dL preoperatively despite optimization.
• Severe Respiratory Diseases:
• Forced expiratory volume (FEV1): \<50%.
• Oxygen saturation: Resting SpO₂ \<88% on room air without supplemental oxygen.
• CO2 retention: PaCO₂ \>50 mmHg.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Related Publications (3)

• Apelian S, Vest A, Yasukawa M, Wellcome J, Kohut A, Imudia AN, Tuli R, Anderson ML, Rutherford T, Andikyan V. Uterine Transposition for Fertility Preservation and Ovarian Conservation in Patients Undergoing Pelvic Radiotherapy. Obstet Gynecol. 2025 Nov 1;146(5):679-689. doi: 10.1097/AOG.0000000000005954. Epub 2025 Jul 3.

  PMID: 40609092 BACKGROUND

• Ribeiro R, Baiocchi G, Moretti-Marques R, Linhares JC, Costa CN, Pareja R. Uterine transposition for fertility and ovarian function preservation after radiotherapy. Int J Gynecol Cancer. 2023 Dec 4;33(12):1837-1842. doi: 10.1136/ijgc-2023-004723.

  PMID: 37898483 BACKGROUND

• Ribeiro R, Rebolho JC, Tsumanuma FK, Brandalize GG, Trippia CH, Saab KA. Uterine transposition: technique and a case report. Fertil Steril. 2017 Aug;108(2):320-324.e1. doi: 10.1016/j.fertnstert.2017.06.016. Epub 2017 Jul 8.

  PMID: 28697913 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Vaagn Andikyan

  USF Health Morsani College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittani Powell, MPH, CCRP

CONTACT

(813) 974-5638; RSCH-IRB@usf.edu

Jennifer Childress, RN, CCRP

CONTACT

813-844-1053; jchildress@tgh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Non-applicable
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a phase I study evaluating feasibility and safety of utero-ovarian transposition (UOT) in young women undergoing whole pelvic radiation therapy (WPXRT) for treatment of rectal or other cancers localized to the pelvis. Rigorous inclusion and exclusion criteria will ensure the selection of appropriate candidates, who will undergo a minimally invasive transposition of their cervix, uterus, tube and ovaries outside the planned radiation fields. Following a brief recovery, the radiation oncology team will proceed with WPXRT to treat each patient's cancer. After completing radiation therapy and systemic chemotherapy, the uterus and adnexa will be surgically returned to their normal anatomical position. Throughout the study, patients will be closely monitored for perioperative outcomes, including surgical complications, hospital stay, reproductive metrics and quality of life.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: February 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: June 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Requests for deidentified clinical data can be submitted beginning 12 months after publication and continue for up to 24 months post publication.
• Access Criteria: Deidentified clinical data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests should be made directly to the Principal Investigator, Dr. Vaagn Andikyan

Locations

US (1)