💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Uteroovarian transposition
Tampa General Hospital
Tampa, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.