Long-term Ovarian Fertility in Patients Treated for Lymphoma. (FERTILymph)

November 7, 2022 updated by: University Hospital, Lille

Long-term Follow-up of Ovarian Function and Fertility in Young Lymphoma Patients Treated by Chemotherapy

This is an observational, single-center, longitudinal cohort study. In order to evaluate the gonadotoxicity of chemotherapy, an AMH monitoring was initiated in 2006 in our fertility observatory in young patients with lymphoma before, during and after chemotherapy. This study is part of the project "She will get better and then want a child" and is supported by the ARS hauts de France (n° DOS/SDES/AR/FIR/2019/282). Our first study published in 2010 shows that AMH decreases sharply during chemotherapy, regardless of the chemotherapy protocol. At the end of chemotherapy, AMH recovery profiles differ according to the protocol received. This follow-up is therefore essential in order to adapt our practices and our preservation strategies, particularly to the type of chemotherapy. Patients are primarily concerned about their chances of subsequent pregnancy, and there is little evidence in the literature about the impact of chemotherapy on ovarian reserve and long-term fertility.

The fisrt objective of our study is to evaluate, at distance from chemotherapy, the evolution of ovarian function in patients treated for lymphoma by evaluating follicular reserve parameters (AMH and antral follicle count) at 5 and 10 years after the end of chemotherapy compared with the initial workup performed before chemotherapy and the workup performed at 12 months after the end of chemotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

270

Contacts and Locations

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

Study Contact

Study Contact Backup

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

lymphoma patients treated with chemotherapy included in the fertility observatory

Description

Inclusion Criteria:

  • Patients with a history of lymphoma treated with chemotherapy
  • followed in the fertility observatory of the Jeanne de Flandre Hospital at the University Hospital of Lille (project "she will heal and then want a child"), who are at least at 5 years since the end of chemotherapy
  • Patients having been informed and having given their written consent to participate in the study.
  • Beneficiary of a social security system.

Exclusion Criteria:

  • Patient not followed in the fertility observatory.
  • Inability of the patient to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
  • Patient opposed to her participation in the study.
  • Patient under guardianship or curatorship.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follicular reserve parameters (AMH and antral follicle count)
Time Frame: at the end of chemotherapy
Follicular reserve parameters (AMH and antral follicle count) at 5 and 10 years after the end of chemotherapy compared with the initial workup performed before chemotherapy and the workup performed at 12 months after the end of chemotherapy
at the end of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of pregnancy at 5 years and 10 years from the end of treatment defined by the achievement of at least one spontaneous or induced pregnancy.
Time Frame: at 5 and 10 years after the end of chemotherapy.
at 5 and 10 years after the end of chemotherapy.
Pregnancy rate obtained by ART (with or without gamete reuse)
Time Frame: at 5 and 10 years after the end of chemotherapy.
defined by the ratio between the number of clinical pregnancies and the number of ART attempts performed (with or without gamete reuse or frozen ovarian tissue).
at 5 and 10 years after the end of chemotherapy.
Rate of miscarriages, ectopic pregnancies, and live births (single, multiple)
Time Frame: at 5 and 10 years after the end of chemotherapy.
defined by the ratio of the number of miscarriages, ectopic pregnancies, and live births to the number of pregnancies obtained by ART (with or without reuse of gametes or frozen ovarian tissue).
at 5 and 10 years after the end of chemotherapy.
Scores on the Reproductive Concerns (RCACS)
Time Frame: at 5 and 10 years after the end of chemotherapy.
at 5 and 10 years after the end of chemotherapy.
Scores Mood (PHQ)
Time Frame: at 5 and 10 years after the end of chemotherapy.
at 5 and 10 years after the end of chemotherapy.
Quality of Life (FACT-G7)
Time Frame: at 5 and 10 years after the end of chemotherapy.
at 5 and 10 years after the end of chemotherapy.
Life Satisfaction (SWLS) scales
Time Frame: at 5 and 10 years after the end of chemotherapy.
at 5 and 10 years after the end of chemotherapy.

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Collaborators

Agence Régionale de Santé Hauts de France

Investigators

  • Principal Investigator: Christine DECANTER, MD,PhD, 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 (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2029

Study Completion (Anticipated)

March 1, 2029

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_0072
  • 2022-A01753-40 (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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