We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414904
Recruitment Status : Withdrawn (Unable to obtain approval)
First Posted : June 4, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Infertility, Male Testosterone Deficiency Other: Exposure: Covid-19 infection

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Determining the Reproductive Health of Men Post-COVID-19 Infection
Actual Study Start Date : June 10, 2020
Actual Primary Completion Date : June 10, 2020
Actual Study Completion Date : June 10, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/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: Exposure: Covid-19 infection
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Semen parameters [ Time Frame: 3 visits (up to 75 days apart) ]
    Sperm concentration (x10^6/ml) between case and control group.

  2. Sperm Parameters [ Time Frame: 3 visits (up to 75 days apart) ]
    Sperm Motility (%) between case and control group.

  3. Sperm Parameters [ Time Frame: 3 visits (up to 75 days apart) ]
    Sperm normal morphology (%) between case and control group.

  4. Hormones measurement [ Time Frame: 3 visits (up to 75 days apart) ]
    Testosterone (nmol/L) between case and control group.

  5. Hormones measurement [ Time Frame: 3 visits (up to 75 days apart) ]
    Follicle Stimulating Hormone(IU/L) between case and control group.

  6. Hormones measurement [ Time Frame: 3 visits (up to 75 days apart) ]
    Luteinising hormone(IU/L) between case and control group.


Secondary Outcome Measures :
  1. Seminal Reactive oxygen species [ Time Frame: 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 [ Time Frame: 3 visits (up to 75 days apart) ]
    Compare Sperm DNA fragmentation rate (%) between case and control group.


Biospecimen Retention:   Samples With DNA
Sperm DNA fragmentation testing only. No sequencing of human genomic DNA will take place.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
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
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414904


Locations
Layout table for location information
United Kingdom
Channa Jayasena
London, Outside U.S./Canada, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04414904    
Other Study ID Numbers: 20HH5998
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
infertility
hypogonadism
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Infertility, Male