Investigating the regulation of male fertility
| ISRCTN | ISRCTN96450750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96450750 |
| Secondary identifying numbers | 156160 |
- Submission date
- 15/01/2017
- Registration date
- 15/03/2017
- Last edited
- 22/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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 March 2023
Who is funding the study?
Imperial College Trust (UK)
Who is the main contact?
Dr Channa N. Jayasena
c.jayasena@imperial.ac.uk
Contact information
Scientific
Imperial College London
6th Floor Commonwealth Building
Hammersmith Hospital
Du Cane Road
London
W2 0NN
United Kingdom
 ORCID ID |
0000-0002-2578-8223 |
|---|---|
| Phone | +44 (0)208 383 3242 |
| c.jayasena@imperial.ac.uk |
Study information
| Study design | Observational cohort study. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Investigating the regulation of male fertility: an observational cohort study |
| Study objectives | 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(s) | West London Research & Gene Therapy Advisory Committee, 15/07/2014, ref: 14/LO/1038 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/07/2014 |
| Completion date | 01/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Male |
| Target number of participants | 2000 |
| Key inclusion criteria | 1. Infertile men 2. 18-65 years of age |
| Key exclusion criteria | 1. History of anaemia 2. Needle phobia 3. Impaired ability to provide full consent to take part in the study |
| Date of first enrolment | 29/09/2014 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W12 0HS
United Kingdom
Sponsor information
Research organisation
510A 5th Floor Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The planned publication date is approximately one year after the trial end date in a high-impact peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/01/2019 | 22/01/2024 | Yes | No | |
| Results article | 06/10/2022 | 22/01/2024 | Yes | No |
Editorial Notes
22/01/2024: Publication references added.
05/05/2020: Due to current public health guidance, recruitment for this study has been paused.
14/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 14/07/2019 to 31/12/2022.
2. The overall trial end date was changed from 14/07/2019 to 01/03/2023.
3. The intention to publish date was changed from 14/07/2020 to 01/03/2024.
