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 range

8 Years – 39 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Ovarian Diseases trials