Determining the Reproductive Health of Men Post-COVID-19 Infection
NCT ID: NCT04414904
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-06-10
2020-06-10
Brief Summary
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1. An increasing proportion of the worldwide population is being infected with COVID-19.
2. There are ongoing and currently unanswered safety concerns about the effects of COVID-19 on reproductive health.
3. 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.
4. The proposed study will be simple, rapid, and authoritative for the UK and worldwide.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case group
* Men 18-50 years of age
* Already attending hospital for another reason
* High risk of prior COVID-19 infection:
* EITHER Prior positive COVID-19 PCR test result
* OR history suggestive of COVID-19 illness
Exposure: Covid-19 infection
Previous history of COVID-19 infection.
Control Group
* 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
No interventions assigned to this group
Interventions
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Exposure: Covid-19 infection
Previous history of COVID-19 infection.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
50 Years
MALE
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Locations
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Channa Jayasena
London, Outside U.S./Canada, United Kingdom
Countries
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References
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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.
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.
Related Links
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The state of the fertility sector 2017-2018
Other Identifiers
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20HH5998
Identifier Type: -
Identifier Source: org_study_id