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Determining the Reproductive Health of Men Post-COVID-19 Infection

Determining the Reproductive Health of Men Post-COVID-19 Infection

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04414904
Enrollment
0
Registered
2020-06-04
Start date
2020-06-10
Completion date
2020-06-10
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male, Testosterone Deficiency

Keywords

infertility, hypogonadism

Brief summary

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.

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.

Interventions

OTHERExposure: Covid-19 infection

Previous history of COVID-19 infection.

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Semen parameters3 visits (up to 75 days apart)Sperm concentration (x10\^6/ml) between case and control group.
Sperm Parameters3 visits (up to 75 days apart)Sperm Motility (%) between case and control group.
Hormones measurement3 visits (up to 75 days apart)Testosterone (nmol/L) between case and control group.

Secondary

MeasureTime frameDescription
Seminal Reactive oxygen species3 visits (up to 75 days apart)Compare seminal reactive oxidative species (RLU/second/10\^6sperm) between case and control group.
Sperm DNA fragmentation rate3 visits (up to 75 days apart)Compare Sperm DNA fragmentation rate (%) between case and control group.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026