RecruitingNot Applicable

Long-term Ovarian Fertility in Patients Treated for Lymphoma.

France270 participantsStarted 2023-08-22

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Follicular reserve parameters (AMH and antral follicle count)

Timeframe: at the end of chemotherapy

Trial details

NCT IDNCT05616325

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-03

Contact for this trial

Christine DECANTER, MD,PhD

0320445962 christine.decanter@chru-lille.fr

View on ClinicalTrials.gov More Lymphoma, Follicular trials