Evaluating a New Gonadotoxic Risk Stratification System

NCT ID: NCT05052632

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-08-05

Brief Summary

The primary objective of this study is to assess if there is an association between a newly described gonadotoxic risk stratification system and post-treatment ovarian reserve as determined by FSH and AMH.

Detailed Description

The Investigator will test the amount of agreement between the two ordinal variables using a kappa statistic at each time point in the first two years of follow up. The Investigator will perform ordinal logistic regression accounting for repeated measures data for participants who are not using contraception. The Investigator will assess participant characteristics to see if the Investigator need to adjust for other covariates including age, race, ethnicity and body mass index (BMI).

Since contraception can mask an elevated FSH surge from gonadal failure, the Investigator will perform a similar model for participants on contraception using AMH only.

Conditions

Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Appiah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Other Identifiers

21-3084

Identifier Type: -

Identifier Source: org_study_id