Clinical trial NCT05616325: Long-term Ovarian Fertility in Patients Treated for Lymphoma.
Official title: Long-term Follow-up of Ovarian Function and Fertility in Young Lymphoma Patients Treated by Chemotherapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphoma, Follicular
Keywords: Ovarian reserve
chemotherapy, antimüllerian hormone, lymphoma, fertility, follicle
antimüllerian hormone, lymphoma, fertility, follicle
lymphoma
follicle
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Agence Régionale de Santé Hauts de France
First posted: 2022-11-15
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lymphoma patients treated with chemotherapy included in the fertility observatory

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Follicular reserve parameters (AMH and antral follicle count)
timeFrame: at the end of chemotherapy
Secondary outcomes:
measure: 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.
timeFrame: at 5 and 10 years after the end of chemotherapy.
measure: Pregnancy rate obtained by ART (with or without gamete reuse)
timeFrame: at 5 and 10 years after the end of chemotherapy.
measure: Rate of miscarriages, ectopic pregnancies, and live births (single, multiple)
timeFrame: at 5 and 10 years after the end of chemotherapy.
measure: Scores on the Reproductive Concerns (RCACS)
timeFrame: at 5 and 10 years after the end of chemotherapy.
measure: Scores Mood (PHQ)
timeFrame: at 5 and 10 years after the end of chemotherapy.
measure: Quality of Life (FACT-G7)
timeFrame: at 5 and 10 years after the end of chemotherapy.
measure: Life Satisfaction (SWLS) scales
timeFrame: at 5 and 10 years after the end of chemotherapy.
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Christine DECANTER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: