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P-366 A fertility preservation register in Italy: the experience of the PreFerIta project
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Abstract
Study question
Data collection quality on Fertility Preservation (FP) varies across countries, and the shortage of well-established official national oncofertility registries limits understanding of FP outcomes
Summary answer
The development of the first italian FP register represents a resource for better defining FP outcome and improve strategies to support clinicians and inform patients.
What is known already
FP has advanced with reproductive medicine, providing options for patients undergoing gonadotoxic cancer treatments also in younger age. Global demand for FP, for both oncological and non-oncological reasons, has increased significantly. However, legislation, professional guidelines, and access is not uniform in Europe. In addition, data collection quality varies across countries, and the absence of official national registries limits understanding of FP outcomes, particularly for ovarian tissue cryopreservation (OTC) and transplantation (OTT). Beyond clinical insights, a dedicated cycle-by-cycle registry could improve access equity and enhance psychosocial outcomes by informing patients about their reproductive options, empowering them in their fertility decisions
Study design, size, duration
The Italian Assisted Reproductive Technology Registry (IARTR) has developed a data collection system for FP treatments in oncology patients and/or those at risk of iatrogenic infertility, known as PreFerIta. From 2021 to 2023, the eight participating centers in the study tested the PreFerIta platform by entering data of 4,693 cryopreservation cycles from 1998 to 2023, along with the outcomes of 402 thawing procedures conducted up to 2023, including both oocytes and ovarian tissue
Participants/materials, setting, methods
An ad-hoc special interest group, including experts from IARTR, clinical representatives from the eight participating centers, and an IT specialist, developed the web-based PreFerIta registry. This system includes two data entry platforms: one for aggregated, retrospective data on cryopreservation and another for prospective, cycle-by-cycle thawing data. Both platforms cover oocytes and ovarian tissue, resulting in four distinct databases. Every center can provide the data accessing their personal area in the registry
Main results and the role of chance
PreFerIta is an online database, both retrospective and prospective, designed to gather FP data. It supports descriptions of fertility recovery care and offers detailed insights into reproductive health in oncology patients. The platform’s cryopreservation section collects aggregated data on the number of counseling, patients, cycles, oocytes and ovarian tissue, categorized by treatment indication and patient age groups. By the end of the project, the database recorded 3,162 cryopreservation cycles for oocytes involving 2,971 patients and 1,531 cycles for ovarian tissue. The database’s most innovative feature is its prospective, cycle-by-cycle thawing section. To test the platform, detailed information was collected on cryopreservation, thawing, transfers or transplantations, ovarian function recovery, pregnancies, deliveries, and live births related to 2001-2023 activity. Regarding oocyte cryopreservation, 341 thawing cycles were performed on 250 patients, resulting in 86 pregnancies, including 77 singleton pregnancies. These led to 50 deliveries, with 58 live births. For ovarian tissue cryopreservation, 61 thawing cycles were performed on 37 patients. Of 61 OTT, 53 were orthotopic, achieving ovarian function recovery in 93% of cases. Among the 12 singleton pregnancies, 9 occurred naturally, and 3 following Assisted Reproductive Technology (ART) treatment. Six live births were recorded from six deliveries
Limitations, reasons for caution
The analysis of cryopreservation for fertility preservation lacks depth, as it relies only on retrospective aggregated data
Wider implications of the findings
The PreFerIta register is the first experience of an Italian database dedicated to FP for oncological and non-oncological reasons, based on a prospective cycle-by-cycle data. Its improvement will provide qualitative insight into oocyte cryopreservation, OTC and OTT outcomes supporting clinicians’ practices and informing patients about their reproductive options.
Trial registration number
No
Oxford University Press (OUP)
Title: P-366 A fertility preservation register in Italy: the experience of the PreFerIta project
Description:
Abstract
Study question
Data collection quality on Fertility Preservation (FP) varies across countries, and the shortage of well-established official national oncofertility registries limits understanding of FP outcomes
Summary answer
The development of the first italian FP register represents a resource for better defining FP outcome and improve strategies to support clinicians and inform patients.
What is known already
FP has advanced with reproductive medicine, providing options for patients undergoing gonadotoxic cancer treatments also in younger age.
Global demand for FP, for both oncological and non-oncological reasons, has increased significantly.
However, legislation, professional guidelines, and access is not uniform in Europe.
In addition, data collection quality varies across countries, and the absence of official national registries limits understanding of FP outcomes, particularly for ovarian tissue cryopreservation (OTC) and transplantation (OTT).
Beyond clinical insights, a dedicated cycle-by-cycle registry could improve access equity and enhance psychosocial outcomes by informing patients about their reproductive options, empowering them in their fertility decisions
Study design, size, duration
The Italian Assisted Reproductive Technology Registry (IARTR) has developed a data collection system for FP treatments in oncology patients and/or those at risk of iatrogenic infertility, known as PreFerIta.
From 2021 to 2023, the eight participating centers in the study tested the PreFerIta platform by entering data of 4,693 cryopreservation cycles from 1998 to 2023, along with the outcomes of 402 thawing procedures conducted up to 2023, including both oocytes and ovarian tissue
Participants/materials, setting, methods
An ad-hoc special interest group, including experts from IARTR, clinical representatives from the eight participating centers, and an IT specialist, developed the web-based PreFerIta registry.
This system includes two data entry platforms: one for aggregated, retrospective data on cryopreservation and another for prospective, cycle-by-cycle thawing data.
Both platforms cover oocytes and ovarian tissue, resulting in four distinct databases.
Every center can provide the data accessing their personal area in the registry
Main results and the role of chance
PreFerIta is an online database, both retrospective and prospective, designed to gather FP data.
It supports descriptions of fertility recovery care and offers detailed insights into reproductive health in oncology patients.
The platform’s cryopreservation section collects aggregated data on the number of counseling, patients, cycles, oocytes and ovarian tissue, categorized by treatment indication and patient age groups.
By the end of the project, the database recorded 3,162 cryopreservation cycles for oocytes involving 2,971 patients and 1,531 cycles for ovarian tissue.
The database’s most innovative feature is its prospective, cycle-by-cycle thawing section.
To test the platform, detailed information was collected on cryopreservation, thawing, transfers or transplantations, ovarian function recovery, pregnancies, deliveries, and live births related to 2001-2023 activity.
Regarding oocyte cryopreservation, 341 thawing cycles were performed on 250 patients, resulting in 86 pregnancies, including 77 singleton pregnancies.
These led to 50 deliveries, with 58 live births.
For ovarian tissue cryopreservation, 61 thawing cycles were performed on 37 patients.
Of 61 OTT, 53 were orthotopic, achieving ovarian function recovery in 93% of cases.
Among the 12 singleton pregnancies, 9 occurred naturally, and 3 following Assisted Reproductive Technology (ART) treatment.
Six live births were recorded from six deliveries
Limitations, reasons for caution
The analysis of cryopreservation for fertility preservation lacks depth, as it relies only on retrospective aggregated data
Wider implications of the findings
The PreFerIta register is the first experience of an Italian database dedicated to FP for oncological and non-oncological reasons, based on a prospective cycle-by-cycle data.
Its improvement will provide qualitative insight into oocyte cryopreservation, OTC and OTT outcomes supporting clinicians’ practices and informing patients about their reproductive options.
Trial registration number
No.
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