TransgenderGIFTNCT07358897
Gender Affirming Hormone Therapy and Immune Function in Trans Individuals - The GIFT Study
An observational study of Transgender, run by Imperial College London.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Transgender
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2026to 7 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults between 18 and 50 years of age with diagnosed gender dysphoria about to start gender-affirming hormone therapy with either oestrogen or testosterone.
Who may be able to join
- Adults between 18 and 50 years of age with diagnosed gender dysphoria about to start gender-affirming hormone therapy with either oestrogen or testosterone.
Who cannot join
- 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)
About this 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.
- Conditions
- Transgender
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune system adaptations to gender affirming hormone therapy
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.
Measured: 3 years
Secondary outcomes (2)
Hormone concentrations
We will measure blood sex hormone levels of individuals on gender affirming hormone therapy
Measured: 3 years
Immune-related blood protein levels
We will measure concentration of immune related proteins in plasma samples from patients on gender affirming hormone therapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start16 Feb 2026 (estimated)
- Primary completion7 Jan 2029 (estimated)
- Study completion7 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358897
- Sponsor's protocol ID
- 182929
- Other IDs
- 361618
- Acronym
- GIFT
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Affirming Hormone Therapy and Immune Function in Trans Individuals - The GIFT Study
- ClinicalTrials.gov ID
- NCT07358897
- Acronym / sponsor ID
- GIFT / 182929
- Conditions
- Transgender
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 7 Jan 2029 (estimated)
- Study completion
- 7 Jan 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults between 18 and 50 years of age with diagnosed gender dysphoria about to start gender-affirming hormone therapy with either oestrogen or testosterone.
Key inclusion criteria (1 listed)
- Adults between 18 and 50 years of age with diagnosed gender dysphoria about to start gender-affirming hormone therapy with either oestrogen or testosterone.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Hormone concentrations
Time frame: 3 years
Immune-related blood protein levels
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune system adaptations to gender affirming hormone therapy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.