Minimal Residual Disease Evaluation on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia (FERTILAM)

December 17, 2025 updated by: University Hospital, Lille

Pilot Study to Assess Minimal Residual Disease on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia

Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation.

This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • CHU Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 2 to 40 year-old, who present at least one molecular marker at acute myeloid leukemia diagnosis and who undergo ovarian cryopreservation for fertility preservation at the time of complete remission, before hematopoietic stem cell transplantation.

Description

Inclusion Criteria:

  • Patient diagnosed with AML
  • At least one molecular marker identified at AML diagnosis
  • Patients who undergo ovarian tissue cryopreservation for fertility preservation in complete remission, before hematopoietic stem cell transplantation.

Exclusion Criteria:

  • Other diagnostic
  • No marker available at AML diagnosis
  • No bone marrow/ovarian fragment available at the time of complete remission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients without detectable MRD in ovarian tissue
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with MRD detected in ovarian tissue and bone marrow.
Time Frame: Up to 1 month
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Saint-Louis Hospital, Paris, France
Canceropôle Nord Ouest

Investigators

  • Principal Investigator: Laurène Fenwarth, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Actual)

September 4, 2022

Study Completion (Actual)

September 4, 2022

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Estimated)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_12
  • 2020-A01513-36 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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