Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (UOT WPXRT)

A Phase I Assessment of Utero-ovarian Transposition (UOT) for Fertility Preservation in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (WPXRT)

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal (Colon or Rectal) Cancer; Pelvic Malignancies; Oncofertility
• Intervention / Treatment: Procedure: Uteroovarian transposition

Detailed Description

This is a phase I study aimed to evaluate feasibility and safety of utero-ovarian transposition (UOT) in young women undergoing whole pelvic radiation therapy (WPXRT) for treatment of a colorectal or other cancers localized to the pelvis. By comprehensively evaluating real-world outcomes for women undergoing this procedure, the proposed work will lay the groundwork necessary to establish UOT as a viable option for fertility preservation and survivorship for this unique patient population. 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, thus sparing transposed organs from radiation exposure. Following a brief recovery, the radiation oncology team will proceed with WPXRT to treat each patient's cancer. If chemotherapy is indicated, it will be completed at this time, prior to the second procedure. After completing radiation therapy and/or chemotherapy, the uterus and adnexa will be surgically returned to their normal anatomical position.

This study will assess surgical outcomes for enrolled subjects undergoing this care plan, assess quality of life and the preservation of fertility and uterine receptivity by multiple objective measures.

Throughout the study, patients will be closely monitored for perioperative outcomes, including surgical complications, hospital stay, and quality of life. Patterns of menstruation, as well as levels of key hormones routinely used to assess fertility (FSH, LH, AMH, and estradiol) will be measured at key time points.

Successful UOT will be defined as the ability to complete the procedure and successfully restore a viable uterus and adnexa capable of supporting normal menstruation and fertility post-radiation therapy.

The resumption of menstrual cycles for six months following the procedure will be evaluated. Quality of life will be evaluated at multiple steps as women undergo the proposed procedures as well as throughout the planned 6 months follow up window.

Data generated by this pilot study will provide critical insights into the feasibility, safety, and potential benefits of UOT as a fertility-preserving and ovarian function-conserving option for patients with pelvic malignancies undergoing WPXRT. Moving forward, data from this study will be used not only to build out the programmatic and clinical infrastructure needed to further evaluate the efficacy of UOT, but also to overcome roadblocks to its successful clinical implementation in the future.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brittani Powell, MPH, CCRP; Phone Number: (813) 974-5638; Email: RSCH-IRB@usf.edu
• Study Contact Backup: Name: Jennifer Childress, RN, CCRP; Phone Number: 813-844-1053; Email: jchildress@tgh.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Principal Investigator: Vaagn Andikyan, MD
      • Contact: Jennifer Childress, RN, CCRP; Phone Number: 813-844-1053; Email: jchildress@tgh.org
      • Contact: Vaagn Andikyan, MD; Phone Number: 813-844-4554; Email: andikyan@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: Women 18 - 40 years of age who wish to preserve their fertility.

2. Malignancy: Diagnosis of pelvic malignancies that require radiotherapy, including:

   1. Colon and rectal cancer with tumors.
   2. Anal cancer.
   3. Other pelvic malignancies that require administration of WPXRT.
3. Desire for Fertility Preservation: The patient expresses a clear desire to preserve fertility and the ability to carry a pregnancy in the future.

4. Preoperative Ovarian Function: The patient must have normal ovarian function, demonstrated by specific hormonal values, including:

   1. Follicle-Stimulating Hormone (FSH): <10 IU/L
   2. Luteinizing Hormone (LH): within normal reference range for reproductive age (typically 1.5-8 IU/L in the early follicular phase).
   3. Anti-Müllerian Hormone (AMH): >1 ng/mL
   4. Estradiol (E2): within the normal range for the follicular phase (usually 30-120 pg/mL).
5. No Distant Metastasis: Absence of metastatic disease confirmed by imaging (CT, MRI, or PET scans).
6. Body Mass Index (BMI) < 35.
7. Signed Informed Consent.

Exclusion Criteria:

1. Advanced Cancer Stage: Patients with locally advanced or metastatic disease.
2. Significant Uterine Pathology: Presence of large uterine fibroids, adenomyosis, or other intrauterine pathologies that would complicate the procedure or future pregnancy.

3. Poor General Health or Comorbidities: Severe medical conditions that contraindicate surgical intervention, that include but not limited to:

   • Cardiovascular Disease:

     1. Recent (within 6 months) myocardial infarction (MI).
     2. Ejection fraction (EF): EF <30%.
     3. Uncontrolled hypertension: Systolic BP >180 mmHg or Diastolic BP >110 mmHg prior to surgery.
     4. Severe aortic stenosis: Valve area <1 cm² with symptomatic status.

   • Uncontrolled Diabetes Mellitus:

     1. Hemoglobin A1c (HbA1c) > 9%
     2. Persistent fasting glucose >250 mg/dL preoperatively despite optimization.

   • Severe Respiratory Diseases:

     1. Forced expiratory volume (FEV1): <50%.
     2. Oxygen saturation: Resting SpO₂ <88% on room air without supplemental oxygen.
     3. CO2 retention: PaCO₂ >50 mmHg.

   • Connective Tissue Disorders:

     1. Severe systemic lupus erythematosus (SLE): Active lupus nephritis with GFR <30 mL/min.
     2. Scleroderma with severe pulmonary hypertension or FVC <50% predicted.
     3. Rheumatoid arthritis with severe cervical spine instability (atlantoaxial subluxation).

   • Severe Inflammatory Bowel Disease (IBD):

     1. Severe Crohn's or ulcerative colitis flares with C-reactive protein (CRP) >10 mg/L and hypoalbuminemia (Albumin <2.5 g/dL).
     2. Severe malnutrition: BMI <18.5 kg/m² or Prealbumin <10 mg/dL

   • Steroid dependency:

     1. Chronic steroid use (>20 mg prednisone daily) with no feasible taper pre-surgery.
4. Prior Pelvic Radiotherapy.
5. Prior history of systemic chemotherapy and immunotherapy that resulted in significant toxicity and residual deficit.
6. Pregnancy: Patients who are currently pregnant are excluded from consideration for uterine transposition.

7. Unsuitable for Ovarian Function Preservation: Women with signs of poor ovarian reserve, including:

   • FSH: >10 IU/L
   • AMH: <1 ng/mL
   • Estradiol: outside normal range.
8. Non-Candidate for Fertility: Patients with contraindications to future pregnancy, such as severe uterine abnormalities or significant risk for pregnancy-related complications.
9. Body Mass Index (BMI) ≥35.
10. Absence of One of the Gonadal Vessels.
11. Other unlisted conditions or diagnoses that, in the opinion of the primary investigator, render the patient an unsuitable candidate for uteroovarian transposition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Uteroovarian transposition arm; 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; 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.; Other Names: uterine transposition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Complications	Postoperative complications will be monitored. All complications will be graded according to the Clavien-Dindo classification system. Unit of Measure: Number of participants with complications.	From enrollment to 4 weeks postsurgery
Menstrual Function	Menstrual function will be evaluated by assessing the return of menses, cycle regularity, and ovulatory characteristics through a standardized postoperative questionnaire. Unit of Measure: Percentage of participants (%)	From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Follicle-Stimulating Hormone (FSH)	Hormonal Function will be evaluated by measuring serum levels of FSH Unit of Measure: Hormone concentration: IU/L	From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Luteinizing Hormone (LH)	Hormonal Function will be evaluated by measuring serum levels of LH. Unit of Measure: Hormone concentration: IU/L.	From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Anti-Mullerian Hormone (AMH)	Hormonal Function will be evaluated by measuring serum levels of AMH. Unit of Measure: Hormone concentration: IU/L.	From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Estradiol	Hormonal Function will be evaluated by measuring serum levels of estradiol. Unit of Measure: Hormone concentration: ng/mL.	From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Quality of Life: FSFI survey	Quality of life will be measured using the FSFI survey. Unit of Measure: FSFI total score.	At enrollment then at 12 weeks and 52 weeks after surgery
Quality of Life: EORTC QLC-C30	Quality of life will be measured using the EORTC QLQ-C30. Unit of Measure: EORTC QLQ-C30 score.	At enrollment then at 12 weeks and 52 weeks after surgery

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Vaagn Andikyan, USF Health Morsani College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: rectal cancer; fertility preservation; oncofertility; pelvic radiation; uterine transposition; utero-ovarian transposition; pelvic malignancies; colorectal malignancies
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Rectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: STUDY008615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request, deidentified clinical data generated during the study will be available from the principal investigator, Dr. Vaagn Andikyan.
• IPD Sharing Time Frame: Requests for deidentified clinical data can be submitted beginning 12 months after publication and continue for up to 24 months post publication.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No