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NCT Number: NCT07358897

Gender Affirming Hormone Therapy and Immune Function in Trans Individuals - The GIFT Study

Our immune systems protect us from infection but can also cause disease, for example by attacking our own bodies (autoimmune disease), or driving chronic inflammation in conditions such as heart disease. The immune systems of men and women function differently, as evidenced by differing rates of disease with autoimmune disease being more common in women whilst men are more susceptible to infection. We don't know why these differences exist, but if we could understand we may be able to develop new treatments to treat or prevent immune driven diseases. So far, we know that both sex chromosomes and hormones affect how the immune system functions, but not the exact contribution of each or how they interact. One way to study this is to work with transgender people. Transgender people identify as a gender different from their sex assigned at birth and some may choose to take the sex hormones of the gender they identify with, which is known as gender affirming hormone therapy (GAHT). Given that these changes affect their sex hormone profile and not their chromosomes, any changes in their immune system would be driven by hormones only. This would help us understand not only how sex hormones shape the immune system more generally, but also the disease risk in transgender people and enable better patient counselling. In this study, transgender patients starting on GAHT at 56 Dean Street clinic in London would be invited to donate blood samples before starting therapy, at 1 month (optional) and at 3 and 6 months. These samples would be analysed at the Laboratory of Medical Sciences to examine how the different types of immune cells change with therapy and how they respond to different immune triggers (stimuli). We aim to recruit 500 individuals and anticipate the study will last up to 3 years.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults between 18 and 50 years of age with diagnosed gender dysphoria about to start gender-affirming hormone therapy with either oestrogen or testosterone.

Exclusion criteria

  • Lack of capacity to consent.
  • Abnormalities in expected pubertal development and pharmacological interventions that could affect levels of gonadal steroids including suspected or confirmed self-treatment with steroid hormone preparations in preceding month (birth control excluded).
  • Serious immunological disease (immune deficiency, autoimmune disease requiring immunomodulatory treatment).
  • Regular immunomodulatory treatment such as prednisolone or biological drugs.
  • In the case of vaccination or symptomatic infection ≤5 days before the visit blood sampling should be postponed by 1 week.
  • Age <18 years or >50 years
  • Completed menopause (persons assigned female sex at birth).
  • Positivity for blood borne viruses (HIV, Hepatitis B, Hepatitis C, HTLV-1)

Treatment and study plan

Primary outcomes

  1. Immune system adaptations to gender affirming hormone therapy

    Time frame: 3 years

    We will measure how immune system populations change quantitatively (i.e. the relative proportions of each subpopulation) and in their responses to different immune stimuli with gender affirming hormone therapy.

Secondary outcomes

  1. Hormone concentrations

    Time frame: 3 years

    We will measure blood sex hormone levels of individuals on gender affirming hormone therapy

  2. Immune-related blood protein levels

    Time frame: 3 years

    We will measure concentration of immune related proteins in plasma samples from patients on gender affirming hormone therapy

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: GIFT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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