Ovarian DiseasesMANCT05048654
A Novel Ovarian Reserve Monitoring Algorithm for Patients at Risk of Ovarian Injury From Gonadotoxic Therapy
An observational study of Ovarian Diseases and Fertility Issues, run by University of Colorado, Denver.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 39 years, women only
- Conditions the study is for
- Ovarian Diseases, Fertility Issues, Gonadal Disorders
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 30 Jun 2029
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 39 years
- Women only
- Child, Adult
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.
Who may be able to join
- · 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
Show all 17Show fewer
- 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
Who cannot join
- 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 this study
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.
Read the detailed description
Study Design: 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.
Group B: 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. AMH and FSH will be drawn at each time point.
Group A: Retrospectively, we will abstract AMH and FSH from survivors seen at CHCO and UCH from October 1st, 2016 to September 31st, 2019 and assess time points.
Approach Aim 1: The Investigator will assess AMH and FSH in both groups and evaluate whether the monitoring algorithm allows for early identification of DOR prior to the occurrence of POI. The investigator will calculate time from end of treatment to diagnosis of DOR and POI to evaluate if the monitoring algorithm detects these conditions earlier than historical controls.
Statistical analysis: The investigator will provide descriptive statistics and time to event analysis by group.
Aim 2: The Investigator will assess time from end of treatment to utilization of ART as defined by ovulation induction with or without insemination, in vitro fertilization, and/or third-party reproduction.
Statistical analysis: The Investigator will provide descriptive statistics and time to event analysis by group (A and B).
Aim 3: The Investigator will assess if early identification of DOR improves prognosis for successful ART for Group B as compared to Group A. The Investigator define success as an AFC greater than or equal to 6 at time of evaluation by REI.
Statistical analysis: The Investigator will provide descriptive statistics for the prevalence of AFC greater than 6 by group (A and B).
Aim 4: The Investigator will characterize barriers to utilization of ART by surveying participants who were referred to REI. The Investigator will assess the following: (1) if participants declined or accepted referral, (2) if they accepted, were they successful, and (3) if they declined, reasons for declining.
- Conditions
- Ovarian Diseases, Fertility Issues, Gonadal Disorders
- Medical subject headings
- Ovarian Diseases, Infertility, Gonadal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year follow up
Secondary outcomes (3)
Time to ART
Assess if the length of time from end of treatment to utilization of ART is different between the two groups.
Measured: 2 year follow up
Evaluate if there is an improved AFC in the new monitoring algorithm group
Assess if the proportion of AFC greater than or equal to 6 at time of evaluation by REI is higher in the new monitoring algorithm group compared to the standard of care.
Measured: 2 year follow up
Characterizing barriers to utilization of ART
We will examine the following: (1) if participants declined or accepted referral, (2) if they accepted, were they successful, and (3) if they declined, reasons for declining.
Measured: 2 year year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Why it stopped: Cancelled by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian DiseasesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Appiah, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048654
- Sponsor's protocol ID
- 21-3085
- Acronym
- MA
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2021
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Ovarian Reserve Monitoring Algorithm for Patients at Risk of Ovarian Injury From Gonadotoxic Therapy
- ClinicalTrials.gov ID
- NCT05048654
- Acronym / sponsor ID
- MA / 21-3085
- Conditions
- Ovarian Diseases, Fertility Issues, Gonadal Disorders
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Cancelled by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design: 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.
Group B: 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. AMH and FSH will be drawn at each time point.
Group A: Retrospectively, we will abstract AMH and FSH from survivors seen at CHCO and UCH from October 1st, 2016 to September 31st, 2019 and assess time points.
Approach Aim 1: The Investigator will assess AMH and FSH in both groups and evaluate whether the monitoring algorithm allows for early identification of DOR prior to the occurrence of POI. The investigator will calculate time from end of treatment to diagnosis of DOR and POI to evaluate if the monitoring algorithm detects these conditions earlier than historical controls.
Statistical analysis: The investigator will provide descriptive statistics and time to event analysis by group.
Aim 2: The Investigator will assess time from end of treatment to utilization of ART as defined by ovulation induction with or without insemination, in vitro fertilization, and/or third-party reproduction.
Statistical analysis: The Investigator will provide descriptive statistics and time to event analysis by group (A and B).
Aim 3: The Investigator will assess if early identification of DOR improves prognosis for successful ART for Group B as compared to Group A. The Investigator define success as an AFC greater than or equal to 6 at time of evaluation by REI.
Statistical analysis: The Investigator will provide descriptive statistics for the prevalence of AFC greater than 6 by group (A and B).
Aim 4: The Investigator will characterize barriers to utilization of ART by surveying participants who were referred to REI. The Investigator will assess the following: (1) if participants declined or accepted referral, (2) if they accepted, were they successful, and (3) if they declined, reasons for declining.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 39 years
- Sex
- Female only
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (17 listed)
- · Female patients ages 8 - 39 years of age
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Does the novel monitoring algorithm (intervention group) detect early Ovarian disfunction
Time frame: 2 year follow up
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.
3 secondary outcomes
Time to ART
Time frame: 2 year follow up
Evaluate if there is an improved AFC in the new monitoring algorithm group
Time frame: 2 year follow up
Characterizing barriers to utilization of ART
Time frame: 2 year year follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Appiah, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Diseases and Fertility Issues, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does the novel monitoring algorithm (intervention group) detect early Ovarian disfunction (time frame: 2 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.