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

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What is being collected

Data Collection

Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Adnexal Diseases

From 8 to 39 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2025
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Last updated: January 28, 2026
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Study start date: December 15, 2025

Actual date on which the first participant was enrolled.

Study Design: 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. Group B: Prospectively, survivors will be evaluated by a member of the FPRLE team in the outpatient clinic at 12 months post-therapy completion and every 6 months to 36 months as part of clinical care. AMH and FSH will be drawn at each time point. Group A: Retrospectively, we will abstract AMH and FSH from survivors seen at CHCO and UCH from October 1st, 2016 to September 31st, 2019 and assess time points. Approach Aim 1: The Investigator will assess AMH and FSH in both groups and evaluate whether the monitoring algorithm allows for early identification of DOR prior to the occurrence of POI. The investigator will calculate time from end of treatment to diagnosis of DOR and POI to evaluate if the monitoring algorithm detects these conditions earlier than historical controls. Statistical analysis: The investigator will provide descriptive statistics and time to event analysis by group. Aim 2: The Investigator will assess time from end of treatment to utilization of ART as defined by ovulation induction with or without insemination, in vitro fertilization, and/or third-party reproduction. Statistical analysis: The Investigator will provide descriptive statistics and time to event analysis by group (A and B). Aim 3: The Investigator will assess if early identification of DOR improves prognosis for successful ART for Group B as compared to Group A. The Investigator define success as an AFC greater than or equal to 6 at time of evaluation by REI. Statistical analysis: The Investigator will provide descriptive statistics for the prevalence of AFC greater than 6 by group (A and B). Aim 4: The Investigator will characterize barriers to utilization of ART by surveying participants who were referred to REI. The Investigator will assess the following: (1) if participants declined or accepted referral, (2) if they accepted, were they successful, and (3) if they declined, reasons for declining.

Official TitleA Novel Ovarian Reserve Monitoring Algorithm for Patients at Risk of Ovarian Injury From Gonadotoxic Therapy
Principal SponsorUniversity of Colorado, Denver
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 8 to 39 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGonadal DisordersInfertilityOvarian DiseasesFemale Urogenital Diseases

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

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