Official Title
Determining the Reproductive Health of Men Post-COVID-19 Infection
Brief Title
Determining the Reproductive Health of Men Post-COVID-19 Infection
Protocol ID
NCT04414904
Lead Sponsor
Imperial College London
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.
Study Period
Enrollment Count
0 participants
Eligibility Criteria
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.
Filters
Infertility, Male
Testosterone Deficiency
WITHDRAWN
ADULT