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Official title Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy
ClinicalTrials.gov ID: NCT07419490
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- Age: Women 18 - 40 years of age who wish to preserve their fertility.
- Malignancy: Diagnosis of pelvic malignancies that require radiotherapy, including:
- Colon and rectal cancer with tumors.
- Anal cancer.
- Other pelvic malignancies that require administration of WPXRT.
You likely can't join if
- Advanced Cancer Stage: Patients with locally advanced or metastatic disease.
- Significant Uterine Pathology: Presence of large uterine fibroids, adenomyosis, or other intrauterine pathologies that would complicate the procedure...
- Poor General Health or Comorbidities: Severe medical conditions that contraindicate surgical intervention, that include but not limited to:
- Cardiovascular Disease:
- Recent (within 6 months) myocardial infarction (MI).
- Ejection fraction (EF): EF \<30%.
See the full eligibility criteria
- Age: Women 18 - 40 years of age who wish to preserve their fertility.
- Malignancy: Diagnosis of pelvic malignancies that require radiotherapy, including:
- Colon and rectal cancer with tumors.
- Anal cancer.
- Other pelvic malignancies that require administration of WPXRT.
- Desire for Fertility Preservation: The patient expresses a clear desire to preserve fertility and the ability to carry a pregnancy in the future.
- Preoperative Ovarian Function: The patient must have normal ovarian function, demonstrated by specific hormonal values, including:
- Follicle-Stimulating Hormone (FSH): \<10 IU/L
- Luteinizing Hormone (LH): within normal reference range for reproductive age (typically 1.5-8 IU/L in the early follicular phase).
- Anti-Müllerian Hormone (AMH): \>1 ng/mL
- Estradiol (E2): within the normal range for the follicular phase (usually 30-120 pg/mL).
- No Distant Metastasis: Absence of metastatic disease confirmed by imaging (CT, MRI, or PET scans).
- Body Mass Index (BMI) \< 35.
- Signed Informed Consent.
- Advanced Cancer Stage: Patients with locally advanced or metastatic disease.
- Significant Uterine Pathology: Presence of large uterine fibroids, adenomyosis, or other intrauterine pathologies that would complicate the procedure or future pregnancy.
- Poor General Health or Comorbidities: Severe medical conditions that contraindicate surgical intervention, that include but not limited to:
- Cardiovascular Disease:
- Recent (within 6 months) myocardial infarction (MI).
- Ejection fraction (EF): EF \<30%.
- Uncontrolled hypertension: Systolic BP \>180 mmHg or Diastolic BP \>110 mmHg prior to surgery.
- Severe aortic stenosis: Valve area \<1 cm² with symptomatic status.
- Uncontrolled Diabetes Mellitus:
- Hemoglobin A1c (HbA1c) \> 9%
- Persistent fasting glucose \>250 mg/dL preoperatively despite optimization.
- Severe Respiratory Diseases:
- Forced expiratory volume (FEV1): \<50%.
- Oxygen saturation: Resting SpO₂ \<88% on room air without supplemental oxygen.
- CO2 retention: PaCO₂ \>50 mmHg.
- Connective Tissue Disorders:
- Severe systemic lupus erythematosus (SLE): Active lupus nephritis with GFR \<30 mL/min.
- Scleroderma with severe pulmonary hypertension or FVC \<50% predicted.
- Rheumatoid arthritis with severe cervical spine instability (atlantoaxial subluxation).
- Severe Inflammatory Bowel Disease (IBD):
- Severe Crohn's or ulcerative colitis flares with C-reactive protein (CRP) \>10 mg/L and hypoalbuminemia (Albumin \<2.5 g/dL).
- Severe malnutrition: BMI \<18.5 kg/m² or Prealbumin \<10 mg/dL
- Steroid dependency:
- Chronic steroid use (\>20 mg prednisone daily) with no feasible taper pre-surgery.
- Prior Pelvic Radiotherapy.
- Prior history of systemic chemotherapy and immunotherapy that resulted in significant toxicity and residual deficit.
- Pregnancy: Patients who are currently pregnant are excluded from consideration for uterine transposition.
- 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.
- Non-Candidate for Fertility: Patients with contraindications to future pregnancy, such as severe uterine abnormalities or significant risk for pregnancy-related complications.
- Body Mass Index (BMI) ≥35.
- Absence of One of the Gonadal Vessels.
- Other unlisted conditions or diagnoses that, in the opinion of the primary investigator, render the patient an unsuitable candidate for uteroovarian transposition.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 months to 40 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.