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

NCT07419490 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-02-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Vaagn Andikyan · USF Health Morsani College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Max Age
40 Months
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2030-06-30
Completion
2031-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07419490 on ClinicalTrials.gov