Determining the Reproductive Health of Men Post-COVID-19 Infection
Status:
Not yet recruiting
Sponsors
Imperial College London
Abstract:
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.
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.
Last Verified:May/31/2020
First Submitted:May/28/2020
Estimated Enrollment Submitted:June/1/2020
First Posted:June/3/2020
Last Update Submitted:June/1/2020
Last Update Posted:June/3/2020
Actual Study Start Date:June/9/2020
Estimated Primary Completion Date:May/13/2021
Estimated Study Completion Date:May/13/2021
Condition or disease:Infertility, Male
Testosterone Deficiency
Intervention/treatment:
Other: Case group
Phase:-
Study design:
Study Type:Observational
Observational Model:Case-Control
Time Perspective:Prospective
Arm group:
ArmIntervention/treatment
Case group
Men 18-50 years of age Already attending hospital for another reason High risk of prior COVID-19 infection: EITHER Prior positive COVID-19 PCR test result OR history suggestive of COVID-19 illness
Other: Case group
Previous history of COVID-19 infection.
Control Group
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
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:Male
Sampling method:Non-Probability Sample
Accepts Healthy Volunteers:No
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.

Outcome:
Primary Outcome Measures
1. Semen parameters [3 visits (up to 75 days apart)]
Sperm concentration (x10^6/ml) between case and control group.
2. Sperm Parameters [3 visits (up to 75 days apart)]
Sperm Motility (%) between case and control group.
3. Sperm Parameters [3 visits (up to 75 days apart)]
Sperm normal morphology (%) between case and control group.
4. Hormones measurement [3 visits (up to 75 days apart)]
Testosterone (nmol/L) between case and control group.
5. Hormones measurement [3 visits (up to 75 days apart)]
Follicle Stimulating Hormone(IU/L) between case and control group.
6. Hormones measurement [3 visits (up to 75 days apart)]
Luteinising hormone(IU/L) between case and control group.
Secondary Outcome Measures
1. Seminal Reactive oxygen species [3 visits (up to 75 days apart)]
Compare seminal reactive oxidative species (RLU/second/10^6sperm) between case and control group.
2. Sperm DNA fragmentation rate [3 visits (up to 75 days apart)]
Compare Sperm DNA fragmentation rate (%) between case and control group.
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Clinical Trial
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