Immune Checkpoint Inhibitor and Fertility Study
Research type
Research Study
Full title
A prospective observational study investigating the impact of immune checkpoint inhibitors for cancer on fertility in males and females of child-bearing age.
IRAS ID
332053
Contact name
Rebecca Lee
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
4 years, 5 months, 30 days
Research summary
This study seeks to discover if immune checkpoint inhibitor (ICI) therapy for cancer could impact fertility. ICIs are a type of cancer treatment that amplify the immune system's ability to identify and kill cancer cells. However, by modifying the immune response, ICIs might inadvertently affect fertility due to the possible misdirection of immune responses towards healthy tissues, including those involved in reproduction.
This study will involve men and women who are about to start ICI therapy. Key fertility indicators will be monitored. For women, these markers include Anti-Müllerian hormone (AMH) levels, assessed through a blood test and indicative of the number of remaining eggs, and antral follicle count, determined by an ultrasound and referring to the number of visible follicles (structures containing eggs) between the second and fifth day of the menstrual cycle. The study will also investigate if ICIs influence the regularity of women's menstrual cycles. For men, the study will monitor changes in sperm concentration, movement, and form. In addition, the study will explore if ICIs could lead to the immune system creating antibodies that could attack sperm.
The above fertility parameters will be evaluated before starting treatment, midway through treatment (six months), at the end of treatment (12 months), and a year after the end (24 months). This will allow examination of whether changes in fertility persist over time. The findings will yield important insights into the effects of ICI therapy on reproductive health. For some patients who have already received curative treatment, such as surgery, and are considering additional (adjuvant) treatment with ICIs, this information could be particularly critical in their decision making.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
24/WM/0208
Date of REC Opinion
20 Nov 2024
REC opinion
Further Information Favourable Opinion