Long-term Ovarian Fertility in Patients Treated for Lymphoma.

NCT ID: NCT05616325

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2029-03-31

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.

Conditions

Lymphoma, Follicular

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Agence Régionale de Santé Hauts de France

UNKNOWN

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine DECANTER, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

Christine DECANTER, MD,PhD

Role: CONTACT

christine.decanter@chru-lille.fr

0320445962 ext. +33

Virginie SIMON, MD

Role: CONTACT

virginie1.simon@chu-lille.fr

0320445962 ext. +33

Other Identifiers

2022-A01753-40

Identifier Type: OTHER

Identifier Source: secondary_id

2022_0072

Identifier Type: -

Identifier Source: org_study_id