Infertility, Male Clinical Trial
Official title:
Determining the Reproductive Health of Men Post-COVID-19 Infection
NCT number | NCT04414904 |
Other study ID # | 20HH5998 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | June 10, 2020 |
Est. completion date | June 10, 2020 |
Verified date | November 2020 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Study rationale 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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 10, 2020 |
Est. primary completion date | June 10, 2020 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Channa Jayasena | London | Outside U.S./Canada |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
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). doi: 10.1111/ijcp.12901. Epub 2017 Mar 20. — View Citation
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. — View Citation
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. Review. — View Citation
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). pii: E920. doi: 10.3390/cells9040920. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Semen parameters | Sperm concentration (x10^6/ml) between case and control group. | 3 visits (up to 75 days apart) | |
Primary | Sperm Parameters | Sperm Motility (%) between case and control group. | 3 visits (up to 75 days apart) | |
Primary | Sperm Parameters | Sperm normal morphology (%) between case and control group. | 3 visits (up to 75 days apart) | |
Primary | Hormones measurement | Testosterone (nmol/L) between case and control group. | 3 visits (up to 75 days apart) | |
Primary | Hormones measurement | Follicle Stimulating Hormone(IU/L) between case and control group. | 3 visits (up to 75 days apart) | |
Primary | Hormones measurement | Luteinising hormone(IU/L) between case and control group. | 3 visits (up to 75 days apart) | |
Secondary | Seminal Reactive oxygen species | Compare seminal reactive oxidative species (RLU/second/10^6sperm) between case and control group. | 3 visits (up to 75 days apart) | |
Secondary | Sperm DNA fragmentation rate | Compare Sperm DNA fragmentation rate (%) between case and control group. | 3 visits (up to 75 days apart) |
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