Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05052632

Conditions

Cancer

Eligibility Criteria

Sex: Female

Age: 8 - 39

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cancer

Study ID

NCT05052632

Start date

Apr 1, 2024

Status verified date

Jul, 2024

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 8 - 39

Healthy Volunteers: Not accepted

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

Enrollment

16690 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Ovarian reserve [ Time Frame: 2 year follow up ]

Central Contacts and Locations

Central contacts

Hadley Kelly, MPH

4135371818hadley.kelly@cuanschutz.edu

Locations

University of Colorado

Recruiting

Denver, Colorado, United States, 80045

Contacts

Leslie Appiah, MD

LESLIE.APPIAH@CUANSCHUTZ.EDU

Guluzar Turan, MD

720-954-7992guluzar.turan@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jul 8, 2024

Last verified

Jul, 2024

Keywords

  • ovarian reserve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-07-08.