Actively Recruiting
Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy
Led by University of South Florida · Updated on 2026-02-19
26
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years who want to preserve fertility
- Diagnosed with pelvic malignancies requiring radiation therapy, including colon, rectal, anal, or other pelvic cancers
- Express a clear desire to preserve fertility and carry a pregnancy in the future
- Normal ovarian function shown by hormone levels: FSH <10 IU/L, LH within normal reproductive range, AMH >1 ng/mL, estradiol in normal follicular phase range
- No evidence of metastatic disease on imaging scans
- Body Mass Index (BMI) below 35
- Signed informed consent
You will not qualify if you...
- Advanced cancer stage with locally advanced or metastatic disease
- Presence of large uterine fibroids, adenomyosis, or other uterine conditions complicating surgery or pregnancy
- Severe medical conditions that make surgery unsafe, including recent heart attack, very low heart function, uncontrolled high blood pressure, severe aortic valve narrowing, uncontrolled diabetes, severe lung disease, severe autoimmune diseases, severe inflammatory bowel disease, severe malnutrition, or chronic steroid use without feasible taper
- Prior pelvic radiation therapy
- Previous systemic chemotherapy or immunotherapy causing significant lasting toxicity
- Current pregnancy
- Poor ovarian reserve with FSH >10 IU/L, AMH <1 ng/mL, or abnormal estradiol levels
- Contraindications to future pregnancy such as severe uterine abnormalities or high pregnancy risk
- Body Mass Index (BMI) 35 or higher
- Missing one of the gonadal blood vessels
- Other conditions deemed unsuitable by the primary investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
Research Team
B
Brittani Powell, MPH, CCRP
CONTACT
J
Jennifer Childress, RN, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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