Long-term Ovarian Fertility in Patients Treated for Lymphoma.
ConditionLymphoma, Follicular
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity Hospital, Lille
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
lymphoma patients treated with chemotherapy included in the fertility observatory
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Follicular reserve parameters (AMH and antral follicle count)
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
Time frame
at the end of chemotherapySecondary outcomes
1
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.2
Pregnancy rate obtained by ART (with or without gamete reuse)
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).
Time frame
at 5 and 10 years after the end of chemotherapy.3
Rate of miscarriages, ectopic pregnancies, and live births (single, multiple)
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).
Time frame
at 5 and 10 years after the end of chemotherapy.4
Scores on the Reproductive Concerns (RCACS)
Time frame
at 5 and 10 years after the end of chemotherapy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Agence Régionale de Santé Hauts de France
Collaborator
Source ClinicalTrials.gov