- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414904
Determining the Reproductive Health of Men Post-COVID-19 Infection
Study rationale
- An increasing proportion of the worldwide population is being infected with COVID-19.
- There are ongoing and currently unanswered safety concerns about the effects of COVID-19 on reproductive health.
- It will be immensely reassuring to rapidly report that COVID-19 has no detectable effects on male endocrine or sperm function. Conversely, if COVID-19 does impair male reproductive health, appropriate screening can be performed in couples trying to conceive, and further research can be undertaken.
- The proposed study will be simple, rapid, and authoritative for the UK and worldwide.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Male infertility results from impaired sperm function, and account for half of all infertility. Fertility services have been reported to cost £325M annually in the UK(4) (REF). Testosterone deficiency is one of the most common hormonal problems affecting men, leading to osteoporosis, type 2 diabetes, obesity and depression(5).
Concerns have been raised about the potential effects of COVID-19 on male reproductive dysfunction (male infertility and testosterone deficiency). A recent study has suggested that COVID-19 may enter human cells by binding to receptors (special gates on cells that recognise a specific molecule) for angiotensin converting enzyme 2 (ACE2)(6) . ACE2 receptors are found at very high levels in the testes. Within the testes, ACE2 is found on developing sperm, the 'nurse cells' that help the sperm grow (Sertoli cells), and also on Leydig cells which are needed to make the male sex hormone testosterone. In summary, this evidence suggests that there is a plausible link why COVID-19 would cause male infertility and testosterone deficiency.
All fertility treatment in the UK is regulated by the Human Fertility and Embryology Authority (HFEA). The HFEA has prohibited on all non-cancer fertility treatment in the UK between April 15th and May 12th 2020 due to the COVID-19 epidemic. It is important to rapidly screen and report whether COVID-19 has any obvious effects in causing male infertility and testosterone deficiency. It must be noted that a recent study(1) reported that COVID-19 is not spread by human semen and therefore, semen processing should not risk staff to COVID-19 infection.
Study Type
Contacts and Locations
Study Locations
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Outside U.S./Canada
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London, Outside U.S./Canada, United Kingdom, W12 0HS
- Channa Jayasena
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
We will be recruiting participants by the following means:
- Posters within Imperial College NHS Healthcare trust
- Advertisements within newspapers
- Online advertisements including in social media websites
- Databases held by Imperial College NHS Healthcare trust whereby men have expressed an interest to participate in future research
- Patients attending the Andrology Department and other reproductive outpatient clinics at Imperial College NHS healthcare trust
Description
Inclusion Criteria:
- Men 18-50 years of age
- Already attending hospital for another reason
- Low risk of prior COVID-19 infection(EITHER Negative positive COVID-19 PCR test result within last 4 weeks OR no history suggestive of COVID-19 illness)
- High risk of prior COVID-19 infection(EITHER Prior positive COVID-19 PCR test result OR history suggestive of COVID-19 illness)
Exclusion Criteria:
- Men with current symptoms of COVID-19 infection
- Men currently self-isolating as per UK government advice for COVID-19 infection
- Needle-phobia
- Impaired ability to provide full consent to take part in the study
- History of co-morbidity likely to affect male reproductive function e.g. undescended testes, removal of testes, testicular cancer, drugs such as corticosteroids or testosterone therapy.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Case group
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Previous history of COVID-19 infection.
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Control Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Semen parameters
Time Frame: 3 visits (up to 75 days apart)
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Sperm concentration (x10^6/ml) between case and control group.
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3 visits (up to 75 days apart)
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Sperm Parameters
Time Frame: 3 visits (up to 75 days apart)
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Sperm Motility (%) between case and control group.
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3 visits (up to 75 days apart)
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Sperm Parameters
Time Frame: 3 visits (up to 75 days apart)
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Sperm normal morphology (%) between case and control group.
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3 visits (up to 75 days apart)
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Hormones measurement
Time Frame: 3 visits (up to 75 days apart)
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Testosterone (nmol/L) between case and control group.
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3 visits (up to 75 days apart)
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Hormones measurement
Time Frame: 3 visits (up to 75 days apart)
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Follicle Stimulating Hormone(IU/L) between case and control group.
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3 visits (up to 75 days apart)
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Hormones measurement
Time Frame: 3 visits (up to 75 days apart)
|
Luteinising hormone(IU/L) between case and control group.
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3 visits (up to 75 days apart)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seminal Reactive oxygen species
Time Frame: 3 visits (up to 75 days apart)
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Compare seminal reactive oxidative species (RLU/second/10^6sperm) between case and control group.
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3 visits (up to 75 days apart)
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Sperm DNA fragmentation rate
Time Frame: 3 visits (up to 75 days apart)
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Compare Sperm DNA fragmentation rate (%) between case and control group.
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3 visits (up to 75 days apart)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.
- Wang Z, Xu X. scRNA-seq Profiling of Human Testes Reveals the Presence of the ACE2 Receptor, A Target for SARS-CoV-2 Infection in Spermatogonia, Leydig and Sertoli Cells. Cells. 2020 Apr 9;9(4):920. doi: 10.3390/cells9040920.
- Wang S, Zhou X, Zhang T, Wang Z. The need for urogenital tract monitoring in COVID-19. Nat Rev Urol. 2020 Jun;17(6):314-315. doi: 10.1038/s41585-020-0319-7.
- Hackett G, Kirby M, Edwards D, Jones TH, Rees J, Muneer A. UK policy statements on testosterone deficiency. Int J Clin Pract. 2017 Mar;71(3-4):e12901. doi: 10.1111/ijcp.12901. Epub 2017 Mar 20.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20HH5998
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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