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Reproductive function in teenage and young adult cancer survivors

Reproductive function in teenage and young adult cancer patients in the UK

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12061770
Enrollment
1000
Registered
2023-03-03
Start date
2022-01-28
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer and reproductive health Cancer

Interventions

This is a multi-centre clinical prospective observational cohort study open to all clinical centres directly involved in the care of teenage and young adults (aged 13-25 years) with cancer. Potentia

Sponsors

University of Edinburgh and NHS Lothian
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 28/01/2025: 1. Willing and able to provide written informed consent (including by parent/guardian where appropriate) 2. Aged 13-25 years 3. First cancer diagnosis or relapse of same diagnosis 4. Requires cancer treatment with targeted, immunological and cell-based therapies (surgery, chemotherapy and radiotherapy are permitted if part of this treatment or if the initial treatment plan changes) Previous inclusion criteria: 1. Willing and able to provide written informed consent (including by parent/guardian where appropriate). 2. Aged 13-25 years old 3. First cancer diagnosis 4. Requires cancer treatment (surgery, chemotherapy including targeted therapies, radiotherapy, bone marrow transplant).

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent 2. Does not require cancer treatment 3. Where treatment is not given with the intention of cure or long-term survival

Design outcomes

Primary

MeasureTime frame
Prevalence of reproductive failure and of gonadal dysfunction measured using diagnosis/treatment regimen at 2 years after diagnosis

Secondary

MeasureTime frame
Current secondary outcome measures as of 08/05/2025: Uptake of fertility preservation services, and long-term reproductive outcomes including ongoing ovulation/spermatogenesis, conception, age at menopause, and the need for hormone replacement. The prevalence of reproductive failure and of gonadal dysfunction by diagnosis/treatment regimen at 1 and 5 years after diagnosis. A blood sample is collected at baseline, and 1-, 2-, 3- and 5-year follow-up. In females, anti-Mullerian hormone (AMH) levels will be measured in serum, data will be analysed in conjunction with follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) levels. For males, Inhibin B will be measured in serum. Inhibin B data will be analysed in conjunction with FSH/LH/testosterone levels. _____ Previous secondary outcome measures: Uptake of fertility preservation services, and long-term reproductive outcomes including ongoing ovulation/spermatogenesis, conception, age at menopause, and the need for hormone replacement. The prevalence of reproductive failure and of gonadal dysfunction by diagnosis/treatment regimen at 1 and 3 years after diagnosis. A blood sample is collected at baseline, and 1-, 2- and 3-year follow-up. In females, anti-Mullerian hormone (AMH) levels will be measured in serum, data will be analysed in conjunction with follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) levels. For males, Inhibin B will be measured in serum. Inhibin B data will be analysed in conjunction with FSH/LH/testosterone levels.

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactAudrey Kuchnowski
audrey.kuchnowski@ed.ac.uk+44 (0)131 242 2669

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026