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Search / Trial NCT05048654

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

Launched by UNIVERSITY OF COLORADO, DENVER · Sep 8, 2021

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor ovarian health in young women who are at risk of losing their fertility due to treatments like chemotherapy or radiation. The goal is to identify those at risk of diminished ovarian reserve (DOR) or primary ovarian insufficiency (POI), which can affect their ability to have children. By using this new monitoring method, the researchers hope to help women get quicker access to fertility treatments if they need them, improving their chances of successful pregnancies later on.

To participate in the study, women aged 8 to 39 who have completed their cancer treatments at least 12 months ago may be eligible. This includes those who have had a cancer diagnosis or other conditions that could threaten their fertility. Participants will receive assessments to check their ovarian health and learn more about their options for preserving their ability to have children in the future. It’s important to know that women with certain conditions, like those who have had both ovaries removed or specific genetic disorders, will not be able to join this trial.

Gender

FEMALE

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

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Patients applied

0 patients applied

Trial Officials

Leslie Appiah, MD

Principal Investigator

University of Colorado, Denver

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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