NCT05052632

Evaluating a New Gonadotoxic Risk Stratification System

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 8 Years – 39 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-08-05
• Completion: 2025-08-05
• First posted: 2021-09-22
• Last updated: 2025-08-13