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|Infertility, Male NIH
|Infertility, Female NIH
There are 7 clinical trials
Infertility is a severely distressing experience for many couples. Depression and anxiety are psychological disorders associated with infertility, and they may worsen during infertility treatments. This study times to understand the changes in the psychological status of infertile patients who had in vitro fertilization (IVF) treatment interrupted or postponed because of the COVID-19 pandemic.
The COVID-19 pandemic brought new challenges to our nationwide healthcare system, with rapid escalation of the number of affected individuals over a handful of weeks. From March 13, a first set of measures was taken to minimise the spread of the virus, which largely impacted societal and economical daily life. A view days later, on March 17, the country was put in "lockdown" and all non-urgent medical treatments were cancelled or postponed. As recommended by the major scientific fertility societies, all non-ivf fertility treatments were discontinued abruptly, whereas started ivf stimulations were continued until oocyte aspiration, where after a freeze-all strategy was applied. There is little information available for women aiming for pregnancy or embarking on assisted conception. Given the modelling of the pandemic, including the time to peak and subsequent tail, considerable delays in conception to substantially attenuate risk may be required, which will inevitably impact patients wellbeing and overall success rates. A questionnaire was developed to explore patients perspectives on different aspects of their fertility treatment during the COVID-19 pandemic. The questionnaire contains the following sections: - demographic variables; - questions regarding the fertility history of the respondent; - questions regarding the impact of fertility treatment cancellation / postponing fertility treatment during COVID-19 on their life, psychological wellbeing and relationship; - questions regarding continuing medical treatment on their own, or seeking treatment elsewhere; - questions regarding the satisfaction of measures taken by their fertility center regarding the COVID-19 pandemic; - questions regarding expectations of further treatments, with focus on safety issues related to the COVID-19 pandemic. Eligible patients will be selected electronically from our database and digital agenda. After selection, patients will be contacted via email to participate. Two reminders will be send in case the questionnaire is not filled out: a first reminder after one week, a second reminder after two weeks.
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: Sperm concentration (x10^6/ml) between case and control group.Measure: Semen parameters Time: 3 visits (up to 75 days apart)
Description: Sperm Motility (%) between case and control group.Measure: Sperm Parameters Time: 3 visits (up to 75 days apart)
Description: Sperm normal morphology (%) between case and control group.Measure: Sperm Parameters Time: 3 visits (up to 75 days apart)
Description: Testosterone (nmol/L) between case and control group.Measure: Hormones measurement Time: 3 visits (up to 75 days apart)
Description: Follicle Stimulating Hormone(IU/L) between case and control group.Measure: Hormones measurement Time: 3 visits (up to 75 days apart)
Description: Luteinising hormone(IU/L) between case and control group.Measure: Hormones measurement Time: 3 visits (up to 75 days apart)
Description: Compare seminal reactive oxidative species (RLU/second/10^6sperm) between case and control group.Measure: Seminal Reactive oxygen species Time: 3 visits (up to 75 days apart)
Description: Compare Sperm DNA fragmentation rate (%) between case and control group.Measure: Sperm DNA fragmentation rate Time: 3 visits (up to 75 days apart)
Recently, the world was shaken awake by a pandemic caused by a novel coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). In most nations drastic isolation measures were taken to minimize the further spread of the Coronavirus Disease 2019 (COVID-19). Being the first pandemic sparked by a Coronavirus, little was known on COVID-19 and its implications on general health. Our understanding on the virus and its potential effects on health is growing. In Belgium, the situation is stabilizing, and doctors and healthcare workers are slowly recommencing routine work and consultations. As also fertility treatments were abruptly interrupted, many patients are in need to resume their treatment. The limited evidence of SARS-CoV-2 on pregnancy seems to be rather satisfying1, but practically nothing is known about the possible impact of an active SARS-CoV-2 infection on female gametes. Viral transmission occurs predominantly through respiratory droplets, but transmission to gametes cannot be ruled out. Since the onset of the pandemic, knowledge about the molecular details of SARS-CoV-2 infection rapidly grew. Coronaviruses are enveloped RNA viruses. For a virus to deliver their genome into the host cell, attachment and entrance into that cell is a crucial step. The coronavirus surface protein spike (S) mediates entry into target cells by binding to a cellular receptor and subsequent fusing of the viral envelope with a host cell membrane. The SARS-CoV-2-S protein (SARS-S) utilizes angiotensin-converting enzyme 2 (ACE2) as a receptor for host cell entry. Host proteases such as transmembrane serine protease 2 (TMPRSS2) are then needed to cleave the viral S protein, allow-ing permanent fusion of the viral and host cell membranes2. Expression of ACE2 and TMPRSS2 has been shown in testicular, uterine and placental cells. Based on available transcriptomic data, co-expression of ACE2 and TMPRSS2 is also seen on oocyte level, but the possible impact on reproduction is unknown. The BSG (basigin or CD147), a receptor on host cells, was also identified as a possible route for viral invasion.
Description: Identification of viral RNA in cumulus-oocyte-complexes, exclusively looking at the material that is considered waste material in a normal oocyte retrievalMeasure: Presence or absence of SARS-CoV-2 in follicular fluid, cumulus cells, immature oocytes and endometrium Time: 1 day
Description: Presence of receptors, identified as possible steps in the entry pathway for SARS-CoV-2Measure: Presence of ACE2, TMPRSS and BSG receptors in cumulus cells, immature oocytes and endometrium Time: 1 day
Non-urgent medical care, such as fertility treatments, has been massively postponed during the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might cause anxiety and depression among infertile couples, who are already exposed to the distressing experience of infertility and for whom the wait for a baby already appears unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and foetus, or on fertility. This study aims to assess the views of infertile couple regarding the potential risks of COVID during their fertility treatment and their personal experience of the COVID pandemic and their expectation for further treatment .
Description: Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment, via a surveyMeasure: Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment pandemic and the discontinuation Time: 1 day
Description: . Risk assessment by the patient, via a survey, regarding SARS-CoV-2 during a fertility treatment or during pregnancy. Perception of the risks linked to SARS-CoV-2 during their fertility treatment or during a pregnancyMeasure: Risk assessment Time: 1 day
Description: Patients'expectations regarding the management of an abrupt closure of the fertility center, via a surveyMeasure: Patients'expectations regarding the management of an abrupt closure of the fertility center Time: 1 day
In France, one couple in eight encounters difficulties to conceive. The diagnosis of infertility frequently leads to symptoms of anxiety and depression. These symptoms appear to be higher than in the general population. Some recent studies have looked at the relationship between anxiety and depression in ART cares. Results are controversial, but it appears that patients with lower levels of anxiety and depression have higher pregnancy rates. Moreover, in couple, women seem to have more symptoms of anxiety and depression than men. First epidemiological studies related to the COVID 19 pandemic have shown strong psychological impact on the general population with an anxiety rate estimated at more than 30%. With COVID 19 pandemic and cessation of ART, it is highly likely that psychic symptoms of anxiety or even depression may have appeared or worsened in women undergoing infertility treatment.
Description: Perceived Stress Scale 10 assess stress in 10 questions with score from 0 to 40. The higher the score is, the more important the stress level is.Measure: Psychological impact assessed by scores of PSS10 scales. Time: 15 minutes
Description: depression Scale with 14 questions. It assesses separately anxiety (score from 0 to 21) and depression (score from 0 to 21).The higher the score is, the more important the anxiety level is.Measure: Psychological impact assessed by scores of HADS scales. Time: 15 minutes
The purpose of this study is to investigate the effects of COVID-19 Vaccination on semen parameters and to determine how long these possible changes may last following vaccination.
Description: As measured from semen samples.Measure: Sperm concentration Time: up to 6 months
Description: As measured from semen samples.Measure: Sperm motility Time: up to 6 months
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports