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

A Phase I Assessment of Utero-ovarian Transposition (UOT) for Fertility Preservation in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (WPXRT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Months to 40 Months
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The resumption of menstrual cycles for six months following the procedure will be evaluated."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests whether surgery to move the womb and ovaries before radiation can be done safely and help protect the ability to have children. It is for women ages 18–40 with cancer in the pelvis who need radiation to the whole pelvis and want to carry a pregnancy in the future. The study also checks ovarian function, periods, and quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a woman age 18–40 and want to keep your ability to have children and carry a pregnancy.
  • You have cancer in the pelvis that needs radiation to the whole pelvis, such as colon, rectal, or anal cancer.
  • Your ovaries work normally. Hormone tests must show FSH below 10 IU/L, AMH above 1 ng/mL, and LH and estradiol in the required normal ranges.
  • Scans show that your cancer has not spread to distant parts of the body.
  • Your body mass index (BMI), a measure based on height and weight, is below 35.
  • You sign a form agreeing to join after learning about the study.

Who can't join

  • Your cancer is advanced in the nearby area or has spread to other parts of the body.
  • You have large fibroids (growths in the womb), womb lining growing into its muscle, or other womb problems that could make surgery or pregnancy difficult.
  • You have a serious health problem that makes surgery unsafe. Examples include severe heart or lung disease, poorly controlled diabetes, certain immune diseases, severe bowel inflammation, poor nutrition, or high-dose steroid use that cannot be reduced.
  • You have had radiation to the pelvis, or past chemotherapy and immunotherapy caused serious side effects with lasting problems.
  • You are pregnant now, or a future pregnancy would be unsafe for you.
  • Tests suggest a low supply of eggs: FSH above 10 IU/L, AMH below 1 ng/mL, or estradiol outside the normal range.
  • Your BMI is 35 or higher, or you are missing one of the blood vessels that supply the ovaries.
  • The lead study doctor decides another condition makes this surgery unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

FL