Condition category
Urological and Genital Diseases
Date applied
15/01/2017
Date assigned
15/03/2017
Last edited
15/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Infertility is when a couple cannot get pregnant (conceive), despite having regular unprotected sex. The underlying cause of infertility is unclear in most men who suffer from the condition. The aim of this study is to find out whether male infertility can be caused by particular changes in DNA (the genetic material) and by unusual levels of reproductive hormones.

Who can participate?
Infertile men aged 18-65.

What does the study involve?
Participants are asked to complete a questionnaire and undergo blood sampling and clinical examination. A semen sample is also tested. Some participants have testicular biopsies (tissue samples from the testicles) as part of their treatment for infertility and a small amount of testicular tissue is stored. Participants are followed up over the telephone by a study investigator (clinician or nurse) on up to two occasions during the 3 years after the study.

What are the possible benefits and risks of participating?
The results of this study will advance the understanding of infertility in men, and may improve diagnostic methods and treatments for couples affected by infertility in the future. The results of the tests performed during this study could lead to incidental findings which are likely to require further medical assessment. In this case, participants are referred for the appropriate medical care that would be offered to an NHS patient. Some participants may experience pain or mild discomfort from giving a blood sample which involves inserting a needle into their arm to take blood. However, blood samples are collected by a trained member of the research team who is experienced in taking blood. All information and results from the study are kept strictly confidential and only used by researchers involved in the study.

Where is the study run from?
Imperial College Healthcare NHS Trust (UK)

When is the study starting and how long is it expected to run for?
July 2014 to July 2019

Who is funding the study?
Imperial College Trust (UK)

Who is the main contact?
Dr Channa N. Jayasena
c.jayasena@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Channa Jayasena

ORCID ID

http://orcid.org/0000-0002-2578-8223

Contact details

Imperial College London
6th Floor Commonwealth Building
Hammersmith Hospital
Du Cane Road
London
W2 0NN
United Kingdom
+44 (0)208 383 3242
c.jayasena@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

156160

Study information

Scientific title

Investigating the regulation of male fertility: an observational cohort study

Acronym

Study hypothesis

The study aims to identify factors that may be causing male infertility. These factors will provide better understanding of male infertility and its underlying pathophysiology.

Ethics approval

West London Research & Gene Therapy Advisory Committee, 15/07/2014, ref: 14/LO/1038

Study design

Observational cohort study.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Male infertility

Intervention

Patients will be recruited via the Andrology department at Hammersmith Hospital, London. The aim is to recruit approximately 2000 men. Participants will be asked to complete a questionnaire, undergo blood sampling and clinical examination. A semen sample will also be analysed. Some participants have testicular biopsies as part of their treatment for infertility and a small amount of testicular tissue will be stored. Data will be processed statistically and used to highlight the key mechanisms underlying male infertility. Participants will be followed up over the telephone by a study investigator (clinician or nurse), on up to two occasions during the 3 years following study recruitment.

Intervention type

Genetic

Phase

Drug names

Primary outcome measures

Genetic/molecular abnormalities, assessed using state-of-the-art techniques at the time including Sanger sequencing, next generation sequencing, array comparative genomic hybridisation (CGH), polymerase chain reaction (PCR) and enzyme assays and/or immunoassays, at baseline

Secondary outcome measures

1. Sperm parameters, measured using routine semen analysis at baseline
2. Smoking status, measured using a questionnaire at baseline
3. Weight, measured using scales at baseline
4. Sperm count abnormalities, measured using routine semen analysis at baseline

Overall trial start date

15/07/2014

Overall trial end date

14/07/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infertile men
2. 18-65 years of age

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

2000

Participant exclusion criteria

1. History of anaemia
2. Needle phobia
3. Impaired ability to provide full consent to take part in the study

Recruitment start date

29/09/2014

Recruitment end date

14/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College Healthcare NHS Trust
London
W12 0HS
United Kingdom

Sponsor information

Organisation

AHSC Joint Research Compliance Office

Sponsor details

510A 5th Floor Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

University/education

Funder name

Imperial College Trust (ref: P52570)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The planned publication date is approximately one year after the trial end date (2020) in a high-impact peer reviewed journal.

IPD sharing plans
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

14/07/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes