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Infertility, MaleNCT04414904

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

An observational study of Infertility, Male and Testosterone Deficiency, run by Imperial College London at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men only
Conditions the study is for
Infertility, Male, Testosterone Deficiency
What is being tested?
Exposure: Covid-19 infection
How many people
0 participants
Where
1 siteUnited Kingdom
Study dates
10 Jun 2020to 10 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Adult

Study population: We will be recruiting participants by the following means: 1. Posters within Imperial College NHS Healthcare trust 2. Advertisements within newspapers 3. Online advertisements including in social media websites 4. Databases held by Imperial College NHS Healthcare trust whereby men have expressed an interest to participate in future research 5. Patients attending the Andrology Department and other reproductive outpatient clinics at Imperial College NHS healthcare trust

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Channa Jayasena

    London, Outside U.S./Canada, W12 0HS

Other trials in United Kingdom

About this study

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.
Read the 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.

Being tested
Exposure: Covid-19 infection
Keywords
infertility, hypogonadism
Medical subject headings
Infertility, Male, Infertility, Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure: Covid-19 infectionOther

    Previous history of COVID-19 infection.

Study groups in NCT04414904
Study groupRoleWhat they receive
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
Receives: Other: Exposure: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Semen parameters

    Sperm concentration (x10^6/ml) between case and control group.

    Measured: 3 visits (up to 75 days apart)

  2. Sperm Parameters

    Sperm Motility (%) between case and control group.

    Measured: 3 visits (up to 75 days apart)

  3. Sperm Parameters

    Sperm normal morphology (%) between case and control group.

    Measured: 3 visits (up to 75 days apart)

  4. Hormones measurement

    Testosterone (nmol/L) between case and control group.

    Measured: 3 visits (up to 75 days apart)

  5. Hormones measurement

    Follicle Stimulating Hormone(IU/L) between case and control group.

    Measured: 3 visits (up to 75 days apart)

  6. Hormones measurement

    Luteinising hormone(IU/L) between case and control group.

    Measured: 3 visits (up to 75 days apart)

Secondary outcomes (2)

  1. Seminal Reactive oxygen species

    Compare seminal reactive oxidative species (RLU/second/10^6sperm) between case and control group.

    Measured: 3 visits (up to 75 days apart)

  2. Sperm DNA fragmentation rate

    Compare Sperm DNA fragmentation rate (%) between case and control group.

    Measured: 3 visits (up to 75 days apart)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start10 Jun 2020
  3. Primary completion10 Jun 2020
  4. Study completion10 Jun 2020

Why it stopped: Unable to obtain approval

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414904
Sponsor's protocol ID
20HH5998
Status last verified
Nov 2020
First submitted
29 May 2020
Last updated
24 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang Z, Xu X. scRNA-seq Profiling of Human Testes Reveals the Presence of the ACE2 Receptor, A Target for SARS-CoV-2 Infection in Spermatogonia, Leydig and Sertoli Cells. Cells. 2020 Apr 9;9(4):920. doi: 10.3390/cells9040920.

    PubMed 32283711

  • Wang S, Zhou X, Zhang T, Wang Z. The need for urogenital tract monitoring in COVID-19. Nat Rev Urol. 2020 Jun;17(6):314-315. doi: 10.1038/s41585-020-0319-7.

    PubMed 32313110

  • Hackett G, Kirby M, Edwards D, Jones TH, Rees J, Muneer A. UK policy statements on testosterone deficiency. Int J Clin Pract. 2017 Mar;71(3-4):e12901. doi: 10.1111/ijcp.12901. Epub 2017 Mar 20.

    PubMed 28318076

  • Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.

    PubMed 32007145

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility, Male and Testosterone Deficiency, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Semen parameters (time frame: 3 visits (up to 75 days apart)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04414904, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.

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