Lymphoma, FollicularFERTILymphNCT05616325
Long-term Ovarian Fertility in Patients Treated for Lymphoma.
An observational study of Lymphoma, Follicular, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Lymphoma, Follicular
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 22 Aug 2023to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: lymphoma patients treated with chemotherapy included in the fertility observatory
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
chu de Lille
Lille
Christine DECANTER, 0033320445962, christine.decanter@chru-lille.fr
About this study
Official title: Long-term Follow-up of Ovarian Function and Fertility in Young Lymphoma Patients Treated by Chemotherapy
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
- Keywords
- Ovarian reserve, chemotherapy, antimüllerian hormone, lymphoma, fertility, follicle, antimüllerian hormone, lymphoma, fertility, follicle, lymphoma, follicle
- Medical subject headings
- Lymphoma, Follicular, Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the end of chemotherapy
Secondary outcomes (7)
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.
Measured: at 5 and 10 years after the end of chemotherapy.
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).
Measured: at 5 and 10 years after the end of chemotherapy.
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).
Measured: at 5 and 10 years after the end of chemotherapy.
Scores on the Reproductive Concerns (RCACS)
Measured: at 5 and 10 years after the end of chemotherapy.
Scores Mood (PHQ)
Measured: at 5 and 10 years after the end of chemotherapy.
Quality of Life (FACT-G7)
Measured: at 5 and 10 years after the end of chemotherapy.
Life Satisfaction (SWLS) scales
Measured: at 5 and 10 years after the end of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start22 Aug 2023
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Régionale de Santé Hauts de France
- Responsible party
- Sponsor
- Investigators
- Christine DECANTER, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616325
- Sponsor's protocol ID
- 2022_0072
- Other IDs
- 2022-A01753-40
- Acronym
- FERTILymph
- Status last verified
- May 2026
- First submitted
- 7 Nov 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Ovarian Function and Fertility in Young Lymphoma Patients Treated by Chemotherapy
- ClinicalTrials.gov ID
- NCT05616325
- Acronym / sponsor ID
- FERTILymph / 2022_0072
- Conditions
- Lymphoma, Follicular
- Keywords
- Ovarian reserve, chemotherapy, antimüllerian hormone, lymphoma, fertility, follicle, antimüllerian hormone, lymphoma, fertility, follicle, lymphoma, follicle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Agence Régionale de Santé Hauts de France
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- lymphoma patients treated with chemotherapy included in the fertility observatory
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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.
Pregnancy rate obtained by ART (with or without gamete reuse)
Time frame: at 5 and 10 years after the end of chemotherapy.
Rate of miscarriages, ectopic pregnancies, and live births (single, multiple)
Time frame: at 5 and 10 years after the end of chemotherapy.
Scores on the Reproductive Concerns (RCACS)
Time frame: at 5 and 10 years after the end of chemotherapy.
Scores Mood (PHQ)
Time frame: at 5 and 10 years after the end of chemotherapy.
Quality of Life (FACT-G7)
Time frame: at 5 and 10 years after the end of chemotherapy.
Life Satisfaction (SWLS) scales
Time frame: at 5 and 10 years after the end of chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Related trials for Lymphoma, Follicular
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine DECANTER, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Follicular, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine DECANTER, MD,PhD (0320445962 ext. +33, christine.decanter@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicular reserve parameters (AMH and antral follicle count) (time frame: at the end of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.