Skip to main content
OpenTrials
Completed

NCT Number: NCT06592846

FERtility After Therapy With Intensive Lymphoma in Young Women: LNH-03 1B, LNH-03 2B, LNH-07 3B, GAINED Follow-up

The FERTILE study is a retrospective cohort study evaluating fertility after intensive treatment with RCHOP14/RCHOP21 or ACVBP in young patients with diffuse large B-cell lymphoma treated in clinical trials conducted by the LYSA group and still alive several years after the end of the trial.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

CH d'Avignon - Hôpital Henri Duffaut, Avignon, France

Loading trial locations.

About this study

The FERTILE study is a retrospective cohort study evaluating fertility after intensive treatment with RCHOP14/RCHOP21 or ACVBP in young patients (≤ 38 years) with diffuse large B-cell lymphoma treated in 4 clinical trials conducted by the LYSA group and still alive several years after the end of the trial.

Chemotherapy treatments used to treat diffuse large B-cell lymphoma in women of childbearing age may cause loss of fertility.

There are few studies dedicated specifically to women treated for non-Hodgkin's lymphoma, particularly in the context of intensive CHOP-based regimens (R-CHOP14/R-CHOP21/R-ACVBP). These studies do not provide any details on the type of treatment and the clinical characteristics of the patients. It is in this context that we propose the FERTILE study.

This study is based on the collection and reuse of data already available in the LNH03-1B, LNH03-2B, LNH07-3B and GAINED clinical trials such as the age of the patients, the treatments, the diagnosis. The results of hormonal assessments and fertility tests (endovaginal ultrasound) will also be consulted in the medical file.

In addition, a questionnaire concerning fertility will be proposed by the physician-investigator.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subjects are women
  • Participation in one of the following clinical trials: LNH 03 1B or LNH 03 2B or LNH 07 3B or GAINED
  • Age at initial diagnosis between 18 years and 38 years inclusive, which has allowed their inclusion in the clinical trial
  • Treated with R-ACVBP or R-CHOP14/R-CHOP21 in these clinical trials
  • No relapse of their diffuse large B-cell lymphoma
  • Possible use of stem cell transplantation during clinical trials
  • Subjects are still alive today

Exclusion criteria

  • Subjects died
  • Subjects lost to follow-up

Treatment and study plan

Primary outcomes

  1. Study fertility by evaluating the rate of spontaneous pregnancy (with live-born children) in women (≤ 38 years) treated for diffuse large B-cell lymphoma in 4 LYSA clinical trials.

    Time frame: Day 0 from date of questionnaire signature

    The fertility rate: spontaneous pregnancy rate (with live births) among young women who wish to have children.

Secondary outcomes

  1. Identify the predictive factors associated with pregnancy success after intensive chemotherapy treatment.

    Time frame: Day 0 from date of questionnaire signature

    Identification of predictive factors associated with pregnancy after lymphoma treatment, assessed by a Cox proportional hazards model.

  2. Identify predictive factors associated with gonadal dysfunction.

    Time frame: Day 0 from the questionnaire signature

    The identification of predictive factors associated with gonadal dysfunction after lymphoma treatment, assessed by a Cox proportional hazards model.

    Methods used to assess ovarian reserve (biochemical tests including basal levels of including basal levels of FSH, LH, estradiol and antimüllerian hormone; ultrasound estradiol and antimüllerian hormone; ultrasound measurements including number of antral follicles and ovarian volume).

  3. Study the different clinical practices concerning the preservation of fertility in LYSA sites.

    Time frame: Day 0 from date of questionnaire signature

    Fertility preservation techniques used in the centres (ovarian stimulation, cryopreservation of ovarian tissue, GnRH agonists, in vitro maturation).

    Methods used to assess ovarian reserve (biochemical tests including basal levels of including basal levels of FSH, LH, estradiol and antimüllerian hormone; ultrasound estradiol and antimüllerian hormone; ultrasound measurements including number of antral follicles and ovarian volume)

Sponsors and collaborators

Lead sponsor

The Lymphoma Academic Research Organisation

Other

Registry information

Acronym: FERTILE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 22, 2025

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.

Published trials that share one or more normalized conditions with this study.