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Trial Title:
Long-term Ovarian Fertility in Patients Treated for Lymphoma.
NCT ID:
NCT05616325
Condition:
Lymphoma, Follicular
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Conditions: Keywords:
Ovarian reserve
chemotherapy, antimüllerian hormone, lymphoma, fertility, follicle
antimüllerian hormone, lymphoma, fertility, follicle
lymphoma
follicle
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
lymphoma patients treated with chemotherapy included in the fertility observatory
Sampling method:
Probability Sample
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
women of childbearing age
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Start date:
March 2023
Completion date:
March 2029
Lead sponsor:
Agency:
University Hospital, Lille
Agency class:
Other
Collaborator:
Agency:
Agence Régionale de Santé Hauts de France
Agency class:
Other
Source:
University Hospital, Lille
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05616325
