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

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07419490
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Months - 40 Months
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 20, 2026
Status verified
Nov 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Success of uterine transposition [ Time Frame: From enrollment to completion of surveillance/monitoring at 52 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606
Jennifer Childress, RN, CCRP
[email protected]
813-844-1053
Vaagn Andikyan, MD
[email protected]
813-844-4554
Vaagn Andikyan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
Tampa General Hospital· Tampa, FL

Related Studies