ProspectiveFemaleAYA - Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes
FemFertilAYA
Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes (ProspectiveFemaleAYA)
2 other identifiers
observational
3,000
0 countries
N/A
Brief Summary
In the past two decades, the evidence-based knowledge on the prevalence and risk factors for gonads impairment, including infertility, following cancer and numerous cancer treatment regimen has significantly increased. However, data remains mostly insufficient for individualized prediction of (future) fertility and pregnancy potential, including the use and success of artificial reproductive technologies (ART). Furthermore, therapies have become increasingly complex as more recent treatment regimen have continuously also implemented novel treatment approaches (e.g. immune therapies such as checkpoint inhibitors) for which no comprehensive data regarding its impact on fertility and pregnancy outcomes is available, yet. It is crucial to carefully balance risk-benefit between fertility preservation (FP) procedures and potential of gonadal function/fertility impairment, to examine the efficiency and safety, as well as to assess patients' satisfaction regarding the FP procedures. Answering these questionsis highly relevant as it has been shown that fertility capacity and post-treatment gonadal function may represent a significant part of quality of life in young cancer survivors. The study therefore aim to set up a large-scale registry of emerging data collection programmes to evaluate the gonadotoxic risks, including the prevalence and course of ovarian dysfunction and/or fertility impairment and premature ovarian insufficiency following specific treatments, identification of further risk factors and predictive markers to enhance precision survivorship research in this field. Additionally, data on the use of fertility preservation/hormonal treatment and patients' satisfaction related to these procedures in Europe will be analysed to support patient-centric care. Reproductive health counselling should not be limited to evaluating the risk of gonadotoxicity and offering fertility preservation to those at risk. It should also include evaluating the impact on post-treatment sexuality, menopausal symptoms management, and the counselling on contraception. In addition to clinical information, whole genome sequence data will be generated for selected study participants with evidence of varying impact of gonadotoxic therapies on reproductive function to find genetic variants associated with risk of reproductive and organ toxicity. The data collection will focus on all different cancer diseases, including diseases which are less common such as different types of sarcomas. This will be a significant development to the current state of information in existing registries. The primary objectives of this prospective analysis of European ongoing adolescent and young adult (AYA) cancer patient cohorts are:
- 1.To establish a database with relevant clinical characteristics at time of diagnosis, cancer therapy received and post-cancer clinical and reproductive outcomes by following AYA cancer patients longitudinally.
- 2.To evaluate the effect of cancer therapies on ovarian function and reproductive potential.
- 3.To evaluate fertility preservation measures performed, their risks and efficacy.
- 4.To evaluate the impact of fertility preservation measures on the risk of cancer relapse.
- 5.To evaluate occurrence of pregnancies/live births naturally conceived (including unplanned) or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue.
- 6.To set up a genetic database based on whole genome sequencing of AYAs of the cohort. For this objective a Substudy 1 : " Development of risk prediction models based on clinical and genetic data " will be conducted.
- 7.To develop prediction models for organ toxicities in cancer patients (objective included in Substudy 1).
- 8.To evaluate the effect of cancer therapies on sexuality and quality of life. For this objective a Substudy 2 : "Sexual Health" will be conducted.
- 9.To evaluate the use and counselling on contraception. For this objective, a Substudy 3 : "Contraception" will be conducted.
- 10.To describe management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms. For this objective a Substudy 4 "Management of POI and Menopause Symptoms" will be conducted.
- 11.To explore patient's satisfaction receiving counseling and/or undergoing fertility preservation. For this objective a Substudy 5 on "Satisfaction with Fertility Preservation" will be conducted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Longer than P75 for all trials
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 20, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2035
June 3, 2026
May 1, 2026
4 years
May 20, 2026
May 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (45)
Constitution of the RedCap database
RecCap database including all study parameters for data harmonisation and centralized access.
June 2030
Genetic database based on whole genome sequencing of AYAs
Data base including Whole-genome sequencing data.
June 2030
The impact of fertility preservation measures on the risk of cancer relapse.
Cancer relapse rates in relation to fertility preservation measures performed.
June 2030
Develop prediction models for organ toxicities in cancer patients.
Development of multimodal prediction models for chemotherapy induced effects on AMH levels, AFC, menses pattern pre-post cancer treatment in relation to cancer diagnosis and therapy.
June 2030
Effect of cancer type on sexuality and quality of life (1).
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 total scores (adjusted for relevant predictors) in patients who had their first consultation with the oncofertility unit before therapies versus those who had not.
June 2030
Effect of cancer type on sexuality and quality of life (2).
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 total scores stratified for type of cancer and type of treatment used.
June 2030
Effect of cancer type on sexuality and quality of life (3).
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 total scores in survivors of cancer traditionally considered highly impactful on sexual health (breast, gynecological, rectum) versus others.
June 2030
Effect of cancer type on sexuality and quality of life (4).
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 scores if contraception use (Y/N) and HRT use (Y/N).
June 2030
Effect of cancer type on sexuality and quality of life (5).
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 question 11 results (communication with healthcare professionals) to patients' characteristics (age, disease, treatment, time from diagnosis, …).
June 2030
Effect of cancer type on sexuality and quality of life (6).
Exploring sexual health and QOL using validated EORTC questionnaires. Correlation between EORTC-SH22 total scores and EORTC-QLQ-C30 scores.
June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (1).
Menses pattern pre-post cancer treatment in relation to cancer therapy.
June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (2).
Menses pattern pre-post cancer treatment in relation to cancer diagnosis.
June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (3).
AFC pre-post cancer treatment in relation to cancer therapy.
June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (4).
AFC pre-post cancer treatment in relation to cancer diagnosis.
June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (5).
AMH levels pre-post cancer treatment in relation to cancer therapy.
June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (6).
AMH levels pre-post cancer treatment in relation to cancer diagnosis.
June 2030
The use of contraception during and after treatment (1).
Longitudinal use of contraception during and after treatment compared to general population
June 2030
The use of contraception during and after treatment (2).
Type of contraceptive used during and after treatment compared to general population
June 2030
The use of contraception during and after treatment (3).
Type of contraception according to diseases
June 2030
The use of contraception during and after treatment (4).
Use of contraception type according to patients' characteristics
June 2030
The use of contraception during and after treatment (5).
Association of unexpected pregnancies and contraception access (EPF ranking scale https://www.epfweb.org/node/89); Contraception counseling and satisfaction (anonymous survey).
June 2030
The use of contraception during and after treatment (6).
Occurrence of unplanned pregnancies according to patients' characteristics
June 2030
The use of contraception during and after treatment (7).
Occurrence of unplanned pregnancies according to patients' diseases.
June 2030
The use of contraception during and after treatment (8).
Occurrence of unplanned pregnancies according to patients' fertility preservation strategies
June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (1).
Association between FP performed and subsequent risk. Risk defined as: Bleeding, infection, thrombosis, postponement of cancer therapies for \>1 week.
June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (2).
Association between Oocyte freezing with ovarian stimulation and risk.
June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (3).
Association between oocyte freezing without ovarian stimulation and subsequent Risk.
June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (4).
Association between ovarian tissue freezing (surgical technique) and subsequent risk
June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (5).
Association between GnRH analogues (agonists, antagonists) and risk
June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (6).
Measures performed: Oocyte freezing with ovarian stimulation Association between FP measure performed and number of oocytes cryopreserved
June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (7).
Measures performed: oocyte freezing without ovarian stimulation Association between FP performed and number of oocytes cryopreserved
June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (8).
Measures performed: ovarian tissue freezing (surgical technique) Association between FP measured performed and amount of tissue cryopreserved.
June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (9).
Measures performed: GnRH analogues (agonists, antagonists) Association between FP performed and AMH recovery
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (1).
Spontaneous pregnancy rates.
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (2)
Spontaneous live birth rates.
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (3).
Pregnancy rates using oocytes
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (4).
Live birth rates using oocytes.
M60
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (5).
Pregnancy rates using ovarian tissue.
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (6).
Live birth rates using ovarian tissue.
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (7).
Pregnancy rates associated to technique of thawing cycles and tissue transplantation.
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (8).
Live birth rates associated to technique of thawing cycles and tissue transplantation.
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (9).
obstetrical complications following the use of cryopreserved oocytes
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (10).
neonatal health following the use of cryopreserved oocytes
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (11).
neonatal health following the use of cryopreserved oocytes
June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (12).
neonatal health following the use of gonadal tissue
June 2030
Secondary Outcomes (14)
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (1).
June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (2).
June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (3).
June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (4).
June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (5).
June 2030
- +9 more secondary outcomes
Eligibility Criteria
Multi-center prospective cohort study of females presenting with and treated for AYA cancers at age 15-39
You may qualify if:
- Female cancer patients aged between 15 and 39 years at diagnosis.
- Receiving a diagnosis of primary cancer 01/01/2025 or later
- Treated with chemotherapy and/or targeted therapy/immunotherapy and/or radiotherapy/ radioactive iodine therapy and/or gynaecological surgery.
- Detailed information on treatment received available.
You may not qualify if:
- Pre-existing known POI at cancer diagnosis.
- Treated by surgery alone (except gynaecological surgery).
- Adult individuals subject of a measure of legal protection and/or patients with severe mental disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Region Stockholmcollaborator
- University of Berncollaborator
- University of Leipzigcollaborator
- Université Libre de Bruxellescollaborator
- Linkoeping Universitycollaborator
- University of Tartucollaborator
- University Hospital Heidelbergcollaborator
- Medical University Innsbruckcollaborator
- Hospital Clínico Universitario de Valenciacollaborator
- University of Genovacollaborator
- Vrije Universiteit Brusselcollaborator
- European Unioncollaborator
- Institute of Oncology Ljubljanacollaborator
- University Hospital, Angerscollaborator
- Hopital Antoine Beclerecollaborator
- Universitair Ziekenhuis Brusselcollaborator
- Ospedale Policlinico San Martinocollaborator
- Careggi Hospitalcollaborator
- Aix Marseille Universitécollaborator
- Centre Leon Berardcollaborator
- Istituto Europeo di Oncologiacollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- University of Edinburghcollaborator
- Fondazione Policlinico Universitario Agostino Gemelli IRCCScollaborator
Biospecimen
Blood for Whole-genome sequencing from a subset of patients. Max 2 x 5 ml.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenny A Rodriguez-Wallberg, Prof. MD
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study coordinator
Study Record Dates
First Submitted
May 20, 2026
First Posted
June 3, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
May 31, 2030
Study Completion (Estimated)
May 31, 2035
Last Updated
June 3, 2026
Record last verified: 2026-05