RecruitingNot ApplicableNCT07419490

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

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


Sponsor

University of South Florida

Enrollment

26 participants

Start Date

Mar 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 MonthsMax Age: 40 Months

Plain Language Summary

Simplified for easier understanding

This study tests a surgical procedure called utero-ovarian transposition — moving the ovaries and uterus out of the radiation field before whole-pelvic radiation therapy — to preserve fertility in young women who need pelvic radiation for cancer treatment. **You may be eligible if...** - You are a woman aged 18 to 40 years - You have a pelvic cancer (such as colorectal, anal, or other pelvic cancers) requiring whole-pelvic radiotherapy - You want to preserve your fertility **You may NOT be eligible if...** - You do not wish to preserve fertility - You are outside the age range - Your cancer or treatment situation makes the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUteroovarian 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.


Locations(1)

Tampa General Hospital

Tampa, Florida, United States

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NCT07419490


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