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

NCT05048654 | Withdrawn DMC

• 1 other identifier: 21-3085
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational cohort study to examine the use of a novel proposed ovarian reserve monitoring algorithm to (1) identify patients who are at risk of DOR and POI from gonadotoxic therapy, (2) minimize time from treatment to utilization of assisted reproductive technologies, and (3) improves prognosis for successful ART based on AFC for patients who pursue fertility or fertility preservation.

Conditions

Ovarian Diseases; Fertility Issues; Gonadal Disorders

Outcome Measures

Primary Outcomes (1)

• Does the novel monitoring algorithm (intervention group) detect early Ovarian disfunction

  We will compare ovarian reserve categories (normal, diminished ovarian reserve, primary ovarian insufficiency), defined using AMH and FSH, in a retrospective group using the standard of care and a prospective group using a new monitoring algorithm.

  2 year follow up

Secondary Outcomes (3)

• Time to ART

  2 year follow up

• Evaluate if there is an improved AFC in the new monitoring algorithm group

  2 year follow up

• Characterizing barriers to utilization of ART

  2 year year follow up

Study Arms (2)

Group A: Retrospective

Retrospectively, there will be an abstract of AMH and FSH from survivors seen at CHCO and UCH from October 1st, 2016 to September 31st, 2019 and assess time points.

Group B: Prospective

Prospectively, survivors will be evaluated by a member of the FPRLE team in the outpatient clinic at 12 months post-therapy completion and every 6 months to 36 months as part of clinical care. Per standard of care AMH and FSH will be drawn at each time point.

Eligibility Criteria

• Age: 8 Years - 39 Years
• Gender Eligibility Details: This study address female population as it is looking at Ovarian reserves only
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study participants will be pre- and post-pubertal females 8 years and older greater seen at the University of Colorado Anschutz Pavilion and/or Children's Hospital Colorado who have received gonadotoxic chemotherapy; radiation; or surgical excision of a reproductive organ for malignancy. The anticipated study population for Group B will be approximately 3,338 per year for five years for an projected total of 16, 690. Group A will have an anticipated study population of 3,338 per year for three years for an projected total of 10,014. For Groups A and B that is a grand total of 26,704.

You may qualify if:

• · 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Ovarian Diseases; Infertility; Gonadal Disorders

Condition Hierarchy (Ancestors)

Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine System Diseases

Study Officials

• Leslie Appiah, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share