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

NCT04414904 | Withdrawn

• 1 other identifier: 20HH5998
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Study rationale

1. 1.An increasing proportion of the worldwide population is being infected with COVID-19.
2. 2.There are ongoing and currently unanswered safety concerns about the effects of COVID-19 on reproductive health.
3. 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. 4.The proposed study will be simple, rapid, and authoritative for the UK and worldwide.

Conditions

Infertility, Male; Testosterone Deficiency

Keywords

infertility; hypogonadism

Outcome Measures

Primary Outcomes (6)

• Semen parameters

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

  3 visits (up to 75 days apart)

• Sperm Parameters

  Sperm Motility (%) between case and control group.

  3 visits (up to 75 days apart)

• Sperm Parameters

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

  3 visits (up to 75 days apart)

• Hormones measurement

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

  3 visits (up to 75 days apart)

• Hormones measurement

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

  3 visits (up to 75 days apart)

• Hormones measurement

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

  3 visits (up to 75 days apart)

Secondary Outcomes (2)

• Seminal Reactive oxygen species

  3 visits (up to 75 days apart)

• Sperm DNA fragmentation rate

  3 visits (up to 75 days apart)

Study Arms (2)

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: 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

Interventions

Exposure: Covid-19 infection OTHER

Previous history of COVID-19 infection.

Case group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Male
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Channa Jayasena

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

Location

Related Publications (4)

• 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.

  PMID: 32283711 BACKGROUND

• 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.

  PMID: 32313110 BACKGROUND

• 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.

  PMID: 28318076 BACKGROUND

• 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.

  PMID: 32007145 BACKGROUND

Related Links

• The state of the fertility sector 2017-2018
• Reference 1

Biospecimen

Retention: SAMPLES WITH DNA

Sperm DNA fragmentation testing only. No sequencing of human genomic DNA will take place.

MeSH Terms

Conditions

Infertility, Male; Infertility; Hypogonadism

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: June 10, 2020
• Primary Completion: June 10, 2020
• Study Completion: June 10, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)