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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05052632
Other study ID # 21-3084
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date May 2028

Study information

Verified date May 2023
Source University of Colorado, Denver
Contact Hadley Kelly, MPH
Phone 4135371818
Email hadley.kelly@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 16690
Est. completion date May 2028
Est. primary completion date May 2027
Accepts healthy volunteers No
Gender Female
Age group 8 Years to 39 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Outcome

Type Measure Description Time frame Safety issue
Primary Ovarian reserve The Investigator will evaluate if there is an association between ovarian reserve (defined using AMH and FSH) and the risk stratification system categories (minimally increased risk, significantly increased risk, and high level of increased risk). Specifically Ovarian reserve goes from normal ([FSH <10] AND [AMH >= 1.0]), Diminished ovarian reserve ([10 <=FSH < 25] or [ 0.5 <= AMH <1.0]), primary ovarian insufficiency ([25<= FSH] or [ 0.5 < AMH]). AMH: ng/ml, FSH: mIU/ml. 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. Investigator will perform ordinal logistic regression accounting for repeated measures for participants who are not using contraception. Investigator will access patient characteristics to see if Investigator need to adjust for other covariates including age, race, ethnicity, and body mass index. 2 year follow up
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