ProspectiveFemaleAYA - Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes

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.

Conditions

• Cancer
• Cancer in Pregnancy
• Infertility
• In Vitro Fertilisation (IVF) Treatment
• Late Effects
• Quality of Life
• Sexual Health Quality of Life
• POI
• Contraception Use

Sponsors & Collaborators

• Region Stockholm

  collaborator OTHER_GOV

• University of Bern

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• University of Leipzig

  collaborator OTHER

• Université Libre de Bruxelles

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• Linkoeping University

  collaborator OTHER_GOV

• University of Tartu

  collaborator OTHER

• University Hospital Heidelberg

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• Hospital Clínico Universitario de Valencia

  collaborator OTHER

• Careggi Hospital

  collaborator OTHER

• University of Genova

  collaborator OTHER

• Vrije Universiteit Brussel

  collaborator OTHER

• Aix Marseille Université

  collaborator OTHER

• Centre Leon Berard

  collaborator OTHER

• Istituto Europeo di Oncologia

  collaborator OTHER

• European Union

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Institute of Oncology Ljubljana

  collaborator OTHER

• University Hospital, Angers

  collaborator OTHER_GOV

• Hopital Antoine Beclere

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Kenny A Rodriguez-Wallberg, Prof. MD · Karolinska Institutet

Eligibility

Min Age

15 Years

Max Age

39 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2030-05-31

Completion

2035-05-31