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New surgery aims to shield fertility in women undergoing pelvic radiation

NCT ID NCT07419490

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase I trial tests a surgical procedure called utero-ovarian transposition (UOT) to temporarily move the uterus, ovaries, and fallopian tubes out of the radiation field in women aged 18-40 with pelvic cancers. The goal is to preserve fertility and ovarian function during whole pelvic radiotherapy. The study will assess safety, feasibility, and long-term outcomes like menstrual function and pregnancy potential.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Utero-ovarian transposition (surgical procedure)
What this could lead to
If successful, this procedure could allow women with pelvic cancers to preserve their ability to have children after radiation therapy.
What could go wrong
This is a small, early-phase trial with only 26 participants, so results may not apply to everyone. Surgery carries risks like complications or failure to preserve fertility.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 months

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

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