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Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

RECRUITINGSponsored by Washington University School of Medicine
Actively Recruiting
SponsorWashington University School of Medicine
Started2025-04-08
Est. completion2026-04-15
Eligibility
Age18 Years – 50 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site

Summary

Female patients with early onset (\<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. Premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. There is an unmet need for innovative techniques to protect ovarian function.

Eligibility

Age: 18 Years – 50 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* Biologic female
* Age between 18 and 50 years old (inclusive)
* Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)
* At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist
* Planning to receive radiation therapy (for any indication)
* Ability to understand and willingness to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Prior pelvic radiation
* Prior cancer therapies that are known to impact ovarian function
* Prior diagnosis of ovarian insufficiency/failure or menopause
* Clinically peri- or post-menopausal

  * For patients \> 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded.
  * For patients ≤ 45 years old, if there is a history of vasomotor symptoms consistent with menopause OR irregular menstruation for ≥3 months OR recent changes in their menstrual cycle \> 14 days, then the patient must be excluded.
* Surgically removed or transposed ovaries
* Pregnant and/or breastfeeding

Conditions14

Anal CancerBladder CancerBreast CancerCancerCervix CancerColon CancerGastric CancerHead and Neck CancerLiver CancerLiver Disease

Locations1 site

Washington University School of Medicine
St Louis, Missouri, 63110
Michael Waters, M.D., Ph.D.314-273-0275m.r.waters@wustl.edu

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