Condition category
Urological and Genital Diseases
Date applied
27/03/2015
Date assigned
07/05/2015
Last edited
07/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 March 2017

Who is funding the study?
Abertawe Bro Morgannwg University Health Board NHS Wales (UK)

Who is the main contact?
Dr Nadja Melo

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nadja Melo

ORCID ID

http://orcid.org/0000-0003-4305-8395

Contact details

SWARU Singleton Hospital Swansea Sketty Lane
Swansea
SA2 8QA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Immune Response and the Pathogen-Female & male fertility interface

Acronym

IRPF study

Study hypothesis

To characterise the anti-fungal host response (Th17) by fertile and infertile women and men

Ethics approval

HRA NRES, 05/02/2015, ref: 15/LO/0258

Study design

Observational, single-centre, cross-sectional study.

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

12/03/2015

Overall trial end date

12/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy patients without fertility problem
2. Patients who are under fertility investigation

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/04/2015

Recruitment end date

12/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ABM UHB NHS Wales UK

Sponsor information

Organisation

ABM UHB NHS Wales UK

Sponsor details

Abertawe Bro Morgannwg University Health Board /Morriston Hospital
Swansea
SA6 6NL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Abertawe Bro Morgannwg University Health Board NHS Wales

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to submit our results in the Immunology and Reproduction Journals around 2017.

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes