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

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05616325

Collaborator

Agence Régionale de Santé Hauts de France (Other)

270

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Follicular

Study Design

Study Type:

Observational

Anticipated Enrollment :

270 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2029

Anticipated Study Completion Date :

Mar 1, 2029

Outcome Measures

Primary Outcome Measures

Follicular reserve parameters (AMH and antral follicle count) [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

Secondary Outcome Measures

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. [at 5 and 10 years after the end of chemotherapy.]
Pregnancy rate obtained by ART (with or without gamete reuse) [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).
Rate of miscarriages, ectopic pregnancies, and live births (single, multiple) [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).
Scores on the Reproductive Concerns (RCACS) [at 5 and 10 years after the end of chemotherapy.]
Scores Mood (PHQ) [at 5 and 10 years after the end of chemotherapy.]
Quality of Life (FACT-G7) [at 5 and 10 years after the end of chemotherapy.]
Life Satisfaction (SWLS) scales [at 5 and 10 years after the end of chemotherapy.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.