Moving the uterus, ovaries, and fallopian tubes out of the pelvis before whole pelvic radiation to preserve fertility.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I trial uses a minimally invasive surgical approach to transpose the cervix, uterus, fallopian tubes, and ovaries outside planned whole pelvic radiation fields prior to radiation, then returns them after cancer therapy is complete. Intraoperative indocyanine green fluorescence and Doppler ultrasound will be used to confirm vascular integrity after mobilization. Outcomes will include technical success of organ mobilization, perioperative complications, timeliness and adherence to planned radiation, and objective measures of ovarian function, uterine receptivity, and patient-reported quality of life. The protocol includes standardized postoperative assessments and follow-up to document fertility-preserving outcomes and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tampa General Hospital
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Vaagn Andikyan — USF Health Morsani College of Medicine
• Study coordinator: Brittani Powell, MPH, CCRP
• Email: RSCH-IRB@usf.edu
• Phone: (813) 974-5638

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.