- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07601451
Outcomes for Patients Who Preserved Their Fertility as Part of Cancer Treatment at the Center for the Study and Preservation of Eggs and Sperm: MaPreservFerti (MaPreservFerti)
Outcomes for Patients Who Preserved Their Fertility as Part of Cancer Treatment at the Center for the Study and Preservation of Eggs and Sperm (CECOS) in Lyon Between 2010 and 2024: an Assessment of Male Parenthood. MaPreservFerti
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)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Eloïse FRAISON, Dr
- Telefonní číslo: +33 04 72 12 94 12
- E-mail: eloise.fraison@chu-lyon.fr
Studijní místa
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-
France
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Bron, France, Francie, 69500
- CECOS, Hôpital Femme Mère Enfant
-
Kontakt:
- Eloïse FRAISON, Dr
- Telefonní číslo: +33 04 72 12 94 12
- E-mail: eloise.fraison@chu-lyon.fr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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 |
The self-assessment form will be sent only once.
Patients will return it through a pre-stamped envelope joined to the form
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The fertility of patients who underwent fertility preservation for cancer treatment at the CECOS in Lyon between 2010 and 2024.
Časové okno: Day 1
|
It will be assessed based on the percentage of patients whose partners had a positive pregnancy test:
|
Day 1
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 69HCL25_0974
- 2025-A02363-46 (Jiný identifikátor: ID-RCB)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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