Immune response and pathogen-fertility
| ISRCTN | ISRCTN12542398 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12542398 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/03/2015
- Registration date
- 07/05/2015
- Last edited
- 18/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Candida albicans is a type of yeast (fungus) naturally found in small amounts in the human body. Candidiasis is a fungal infection caused by the overgrowth of this yeast. Candidiasis can occur in almost any part of the body, and anyone can develop it. However, certain groups of people are more at risk. These include the elderly, critically ill people, people with weakened immune systems and some medicines. It is thought that Candidiasis has an impact on both male and female infertility, but this is not fully understood. While the role of fungal infections and Th17-related diseases in female infertility has been documented, the vast majority of the studies have used rats and mice as subjects; whether or not the results would be the same for humans is not known. A particular subset of immune cells (Th17 cells) ensures a robust anti-fungal response in healthy people. The aim of our study is to characterise the immune response (Th17) by both fertile and infertile couples (men and women).
Who can participate?
Healthy participants and patients who are under investigation for fertility problems.
What does the study involve?
White (mononuclear) blood cells from fertile and infertile couples are tested for production of the cytokine IL-17 (hallmark cytokine of the anti-fungal Th17 response) after in vitro stimulation with Candida. The samples (saliva, vaginal swab and semen) are also tested for Candida colonization.
What are the possible benefits and risks of participating?
Participants will benefit in terms of prevention, identification of high risk for development of Candida infection, in particular, for participants without symptoms, the potential for reproductive complications and treatment. The identification of additional specific risk factors in women and/or their partners might aid their fertility treatment and this is one expected outcome of the proposed study.
Where is the study run from?
Abertawe Bro Morgannwg University Health Board NHS Wales (UK)
When is the study starting and how long is it expected to run for?
March 2015 to June 2021
Who is funding the study?
Abertawe Bro Morgannwg University Health Board NHS Wales (UK)
Who is the main contact?
Dr Nadja Melo
Contact information
Scientific
SWARU Singleton Hospital Swansea Sketty Lane
Swansea
SA2 8QA
United Kingdom
 ORCID ID |
0000-0003-4305-8395 |
|---|
Study information
| Study design | Observational, single-centre, cross-sectional study. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | Immune Response and the Pathogen-Female & male fertility interface |
| Study acronym | IRPF study |
| Study objectives | To characterise the anti-fungal host response (Th17) by fertile and infertile women and men |
| Ethics approval(s) | HRA NRES, 05/02/2015, ref: 15/LO/0258 |
| Health condition(s) or problem(s) studied | The objective of our study is to characterise the anti-fungal host response (Th17) by fertile and infertile (women and men) couples. |
| Intervention | Blood mononuclear cells from fertile and infertile couples will be tested for production of the cytokine IL-17 (hallmark cytokine of the anti-fungal Th17 response) after in vitro stimulation with Candida. The samples (saliva, vaginal swab and semen) also will be assessed for Candida colonization. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Immune response of infertile patients will be evaluated by production of the cytokine IL-17 (hallmark cytokine of the anti-fungal Th17 response) after in vitro stimulation with Candida. |
| Secondary outcome measures | The samples (saliva, vaginal swab and semen) also will be assessed for Candida colonization. |
| Overall study start date | 12/03/2015 |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Healthy patients without fertility problem 2. Patients who are under fertility investigation |
| Key exclusion criteria | 1. Pregnant patients 2. Patients diagnosed with HIV or hepatitis 3. Intravenous drug users 4. Individuals unable to provide informed consent 5. Those who have participated in clinical research in the last 6 months |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 12/03/2017 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
United Kingdom
Sponsor information
Hospital/treatment centre
Abertawe Bro Morgannwg University Health Board /Morriston Hospital
Swansea
SA6 6NL
Wales
United Kingdom
"ROR" |
https://ror.org/04zet5t12 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | We intend to submit our results in the Immunology and Reproduction Journals around 2017. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
18/05/2020: The overall trial end date was changed from 30/05/2019 to 30/06/2021.
30/05/2018: The overall trial end date has been changed from 30/06/2018 to 30/05/2019.
14/03/2018: Overall trial end date changed from 30/03/2018 to 30/06/2018
07/03/2018: Plain English Summary updated in line with changes to overall trial end date.
05/03/2018: Overall trial end date changed from 12/03/2017 to 30/03/2018
