WithdrawnNot Applicable

A Novel Ovarian Reserve Monitoring Algorithm for Patients at Risk of Ovarian Injury From Gonadotoxic Therapy

Stopped: Cancelled by PI

0Started 2025-12-15

Plain-language summary

This is an observational cohort study to examine the use of a novel proposed ovarian reserve monitoring algorithm to (1) identify patients who are at risk of DOR and POI from gonadotoxic therapy, (2) minimize time from treatment to utilization of assisted reproductive technologies, and (3) improves prognosis for successful ART based on AFC for patients who pursue fertility or fertility preservation.

Who can participate

Age range8 Years – 39 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * · Female patients ages 8 - 39 years of age * Seen in CHCO or AMC outpatient clinics for any of the following reasons: * At risk for fertility problems (Z91.89) * Encounter for fertility preservation counseling (Z31.62) * Primary ovarian insufficiency * Premature ovarian failure/premature menopause * Diminished ovarian reserve * At least 12 months post-completion of chemotherapy and/or radiation * History of a fertility-threatening diagnosis receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy, including but not limited to: * Any type of cancer/malignancy * Rheumatoid arthritis * Systemic lupus erythematosus * Aplastic anemia * Fanconi anemia * Diamond-Blackfan syndrome * Hurler syndrome * Other autoimmune conditions Exclusion Criteria: * Disorders of sexual development (i.e., gonadal dysgenesis, Turner syndrome/mosaicism, etc.) * History of bilateral oophorectomy * Transgender patients not receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy * Inability to consent/assent

What they're measuring

Does the novel monitoring algorithm (intervention group) detect early Ovarian disfunction

Timeframe: 2 year follow up

Trial details

NCT IDNCT05048654

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31