Determining the Reproductive Health of Men Post-COVID-19 Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04414904|
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
- 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|
|Estimated Enrollment :||100 participants|
|Official Title:||Determining the Reproductive Health of Men Post-COVID-19 Infection|
|Estimated Study Start Date :||June 10, 2020|
|Estimated Primary Completion Date :||May 14, 2021|
|Estimated Study Completion Date :||May 14, 2021|
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
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|
|Contact: Channa Jayasena email@example.com|