Long-term Ovarian Fertility in Patients Treated for Lymphoma.

Lymphoma, Follicular Clinical Trial

— FERTILymph  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05616325
• Other study ID #: 2022_0072
• Secondary ID: 2022-A01753-40
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: March 2029

Study information

• Verified date: November 2022
• Source: University Hospital, Lille
• Contact: Christine DECANTER, MD,PhD
• Phone: 0320445962
• Email: christine.decanter[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: March 2029
• Est. primary completion date: March 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Agence Régionale de Santé Hauts de France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at the end of chemotherapy
Secondary	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.
Secondary	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).	at 5 and 10 years after the end of chemotherapy.
Secondary	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).	at 5 and 10 years after the end of chemotherapy.
Secondary	Scores on the Reproductive Concerns (RCACS)		at 5 and 10 years after the end of chemotherapy.
Secondary	Scores Mood (PHQ)		at 5 and 10 years after the end of chemotherapy.
Secondary	Quality of Life (FACT-G7)		at 5 and 10 years after the end of chemotherapy.
Secondary	Life Satisfaction (SWLS) scales		at 5 and 10 years after the end of chemotherapy.