Determining the Reproductive Health of Men Post-COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04414904|
Recruitment Status : Withdrawn (Unable to obtain approval)
First Posted : June 4, 2020
Last Update Posted : November 24, 2020
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- 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.
|Condition or disease||Intervention/treatment|
|Infertility, Male Testosterone Deficiency||Other: Exposure: Covid-19 infection|
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 :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Determining the Reproductive Health of Men Post-COVID-19 Infection|
|Actual Study Start Date :||June 10, 2020|
|Actual Primary Completion Date :||June 10, 2020|
|Actual Study Completion Date :||June 10, 2020|
Other: Exposure: Covid-19 infection
Previous history of COVID-19 infection.
- Semen parameters [ Time Frame: 3 visits (up to 75 days apart) ]Sperm concentration (x10^6/ml) between case and control group.
- Sperm Parameters [ Time Frame: 3 visits (up to 75 days apart) ]Sperm Motility (%) between case and control group.
- Sperm Parameters [ Time Frame: 3 visits (up to 75 days apart) ]Sperm normal morphology (%) between case and control group.
- Hormones measurement [ Time Frame: 3 visits (up to 75 days apart) ]Testosterone (nmol/L) between case and control group.
- Hormones measurement [ Time Frame: 3 visits (up to 75 days apart) ]Follicle Stimulating Hormone(IU/L) between case and control group.
- Hormones measurement [ Time Frame: 3 visits (up to 75 days apart) ]Luteinising hormone(IU/L) between case and control group.
- Seminal Reactive oxygen species [ Time Frame: 3 visits (up to 75 days apart) ]Compare seminal reactive oxidative species (RLU/second/10^6sperm) between case and control group.
- Sperm DNA fragmentation rate [ Time Frame: 3 visits (up to 75 days apart) ]Compare Sperm DNA fragmentation rate (%) between case and control group.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Male|
|Sampling Method:||Non-Probability Sample|
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
- 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)
- Men with current symptoms of COVID-19 infection
- Men currently self-isolating as per UK government advice for COVID-19 infection
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414904
|London, Outside U.S./Canada, United Kingdom, W12 0HS|
|Responsible Party:||Imperial College London|
|Other Study ID Numbers:||
|First Posted:||June 4, 2020 Key Record Dates|
|Last Update Posted:||November 24, 2020|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|