NCT07601451

Brief Summary

Improvements in diagnostic methods and cancer treatments have led to a steady increase in survival rates. The 5-year survival rate for men diagnosed with cancer between the ages of 15 and 39 has exceeded 81%. As a result, quality of life-and in particular, addressing the issue of parenthood-has become essential. Cancer treatments-surgery, radiation therapy, and chemotherapy-can significantly impair fertility. They may cause sexual dysfunction (anejaculation, anerection), androgen deficiency, or permanent impairment of spermatogenesis. Yet the desire for parenthood ranks among the top three life goals of patients newly diagnosed with cancer, and 50% of patients wish to have a child in the future. Preserving male fertility is therefore a crucial issue. Before puberty, this can be done by taking a testicular tissue sample, although this is still considered experimental. After puberty, a sample taken from ejaculate allows for the storage of sperm straws. Thus, when a couple wishes to conceive, following a potential reassessment of spermatogenesis if it is impaired, Assisted Reproductive Technology (ART) can be performed with or without the frozen sperm. According to the literature, the sperm is typically used within 10 years of fertility preservation. Little data has been collected regarding whether men with a history of cancer conceive naturally or not. It is therefore important to gather this information regarding fatherhood, particularly whether men with a history of cancer have used ART or not, and whether frozen sperm was used or not, based on the results of the follow-up semen analysis performed after treatment. Primary objective To describe fertility-whether spontaneous or following assisted reproductive technology (ART)-with or without the use of preserved gametes, among patients who underwent fertility preservation for cancer treatment at the CECOS in Lyon between 2010 and 2024. Secondary objective: To assess the population of men who preserved their fertility prior to cancer treatment at the Center for the Study and Preservation of Eggs and Sperm (CECOS) in Lyon between 2010 and 2024, specifically:

  • The number and clinical and epidemiological characteristics of the patients.
  • Describe post-cancer fertility
  • Understand CECOS's care protocols to improve the patient care pathway.
  • Describe the psychological difficulties at the time of collection that prevented the procedure and thus the preservation of fertility.
  • Determine the fate of preserved straws that were not used Methodology:
  • Retrospective analysis of data from the CECOS in Lyon between 2010 and 2024.
  • Information collected from the database: patient age, indication, type of fertility preservation performed (testicular tissue or ejaculate)
  • Subsequently, a paper and electronic questionnaire was sent to these same patients to collect data on their fertility following fertility preservation.
  • Information collected via the questionnaires: marital status, place of residence, paternity prior to cancer, type of cancer, treatment received, achievement of pregnancy after cancer and method (spontaneous pregnancy, reuse of straws at the center, or ART at another center), donation of gametes to research, or destruction if unused. The CECOS in Lyon is an integral part of the Department of Reproductive Medicine and Biology at the Hopsices Civils de Lyon. Population studied: This study focuses on patients with a history of cancer who underwent gonadotoxic treatment and preserved their fertility at the CECOS in Lyon between 2010 and 2024 Inclusion criteria: This study will include patients who:
  • were between the ages of 18 and 60 at the time of fertility preservation
  • underwent fertility preservation at the CECOS in Lyon between January 1, 2010, and December 31, 2024.
  • underwent fertility preservation in the context of cancer treatment
  • who have indicated their consent to participate in the study by completing the questionnaire Exclusion criteria:
  • Persons deprived of their liberty by a judicial or administrative decision
  • Persons receiving psychiatric care
  • Persons admitted to a health or social care facility for purposes other than research
  • Adults subject to a legal protection measure (guardianship, conservatorship) Procedure: An information sheet will be sent to patients regarding the analysis of their medical data collected during their care, along with a questionnaire (see attached questionnaire) for the collection of prospective data. The materials will be sent either by mail (with a stamped envelope for free return shipping as part of the study) or electronically via a dedicated and secure CECOS email address for email responses. Number of subjects : 950 Study duration : 1 year Study location : Center for the Study and Preservation of Eggs and Sperm (CECOS)

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 15, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

Male cancer treatmentOncofertilityMale fertility preservationSperm cryopreservation

Outcome Measures

Primary Outcomes (1)

  • The fertility of patients who underwent fertility preservation for cancer treatment at the CECOS in Lyon between 2010 and 2024.

    It will be assessed based on the percentage of patients whose partners had a positive pregnancy test: * either spontaneously after 12 months of unprotected intercourse * or following Assisted Reproductive Technology (ART): * with the use of cryopreserved gametes * without the use of cryopreserved gametes, as a follow-up semen analysis allowed for the use of non-frozen gametes * with the use of donor sperm.

    Day 1

Study Arms (1)

Targeted patients

Patients who undergone fertility preservation after gonadotoxic cancer treatments in the Lyon CECOS between 2010 and 2024 will receive a self-assessment form. After completing it they will return it to the center for analysis

Other: Patient self-assessment form

Interventions

The self-assessment form will be sent only once. Patients will return it through a pre-stamped envelope joined to the form

Targeted patients

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergone fertility preservation after gonadotoxic cancer treatments in the Lyon CECOS between 2010 and 2024.

You may qualify if:

  • were between the ages of 18 and 60 at the time of fertility preservation
  • Underwent fertility preservation at the CECOS in Lyon between January 1, 2010, and December 31, 2024.
  • underwent fertility preservation in the context of cancer treatment
  • who have indicated their consent to participate in the study by completing the questionnaire

You may not qualify if:

  • Persons deprived of their liberty by a judicial or administrative decision
  • Persons receiving psychiatric care
  • Persons admitted to a health or social care facility for purposes other than research
  • Adults subject to a legal protection measure (guardianship, conservatorship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CECOS, Hôpital Femme Mère Enfant

Bron, France, 69500, France

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations