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Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial

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 Years to 50 Years
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

Not stated in the study description — ask the study team about visits and procedures.

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 study tests radiation treatment designed to help protect the ovaries. It is for women ages 18 to 50 who still have regular periods and plan to receive radiation treatment.

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.

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

Eligibility

Who can join

  • Are biologically female.
  • Are 18 to 50 years old.
  • Have regular periods and no symptoms such as hot flashes.
  • Have at least one ovary clearly visible on a CT or MRI scan, as confirmed by a doctor who reads scans.
  • Plan to receive radiation treatment for any reason.
  • Can understand the study consent form and are willing to sign it.

Who can't join

  • Have had radiation to the pelvis, the lower belly area.
  • Have had cancer treatments known to affect how the ovaries work.
  • Have been diagnosed with ovaries that do not work well, ovarian failure, or menopause.
  • Are nearing menopause or have gone through it.
  • If older than 45: have a history of symptoms such as hot flashes or irregular periods.
  • If 45 or younger: have a history of menopause-like hot flashes, irregular periods for at least 3 months, or a recent change of more than 14 days in the time between periods.
  • Have had ovaries removed or moved by surgery.
  • Are pregnant or breastfeeding.

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

Official eligibility criteria

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

Study sites (1)

MO

  • Washington University School of Medicine · St Louis, MO 63110Michael Waters, M.D., Ph.D. · Study contact · 314-273-0275 · m.r.waters@wustl.eduMichael Waters, M.D., Ph.D. · Principal investigatorDaniel Hong, M.D. · Sub-investigatorCarl DeSelm, M.D., Ph.D. · Sub-investigatorMore trials in St Louis