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NCT Number: NCT05616325

Long-term Ovarian Fertility in Patients Treated for Lymphoma.

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.

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Key information

Conditions

Lymphoma, Follicular Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Follicular reserve parameters (AMH and antral follicle count)

    Time frame: 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 outcomes

  1. 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.

    Time frame: at 5 and 10 years after the end of chemotherapy.

  2. Pregnancy rate obtained by ART (with or without gamete reuse)

    Time frame: 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).

  3. Rate of miscarriages, ectopic pregnancies, and live births (single, multiple)

    Time frame: 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).

  4. Scores on the Reproductive Concerns (RCACS)

    Time frame: at 5 and 10 years after the end of chemotherapy.

  5. Scores Mood (PHQ)

    Time frame: at 5 and 10 years after the end of chemotherapy.

  6. Quality of Life (FACT-G7)

    Time frame: at 5 and 10 years after the end of chemotherapy.

  7. Life Satisfaction (SWLS) scales

    Time frame: at 5 and 10 years after the end of chemotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine DECANTER, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Virginie SIMON, MD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Agence Régionale de Santé Hauts de France

Registry information

Official study title

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

Acronym: FERTILymph

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Nov 15, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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