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Coronavirus Infections

Coronaviridae Infections

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RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center

SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics

Florence BRUGNON, MD, PhD

During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.

To perform this, all patient undergoing oncological fertility preservation will be evaluated for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia, pharyngodynia). In addition, a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center. Seminal fluid and spermatozoa will be separated by density gradient centrifugation for a posteriori molecular analysis of SARS-CoV-2 presence.

Will thus be measured, within the same ejaculate, the concordance between the presence of SARS-CoV-2 in the seminal fluid and in the sperm cells fraction.

The investigators will also determine if the virus presence in the sperm is related with :

* (i) the presence of SARS-CoV-2 in the nasal swab;
* (ii) patient symptomatology;
* (iii) a specific serological profile;
* (iv) a particular oncological pathology and / or treatment. The investigators may also find out if the presence of the SARS-CoV-2 in semen affects sperm quality.

This study will be the first one examining the presence of SARS-CoV-2 in semen from cancer patients. This will guarantee the safety of fertility preservation procedures during the COVID-19 pandemic.

Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?

Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?

Seminal fluid and spermatozoa will be separated by density gradient centrifugation, and SARS-CoV-2 will be detected by RT-qPCR in the both fractions.

We will compare SARS-CoV-2 RT-PCR results of seminal fluid and the spermatozoa fractions of the same ejaculate

we will correlate the SARS-CoV-2 detection (using RT- qPCR) in nasopharyngeal swab, seminal fluid and spermatozoa fractions

Any patient undergoing oncological fertility preservation will be evaluated for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia, pharyngodynia). We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with COVID symptoms

Serological tests (Sars-CoV2) will be carried out. We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with specific COVID serological profiles

We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with patient's oncological pathologies and treatments

Before semen density gradient centrifugation and cryopreservation, standards sperm analysis will be performed according to the WHO guideline (2020). We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with standards sperm parameters

Agence de La Biomédecine

University Hospital, Clermont-Ferrand

Adult and post-pubertal males, 13 years of age or older, presenting to clinic because diagnosed with cancer, who wish to preserve their future fertility. Sperm and blood collected for analysis. If minors, parents or guardians have to give consent to the procedure while the boys give their assent.

This is a prospective observational cohort study.

Sperm Collection and Freezing (Cryopreservation), Blood Collection for analysis

Sperm and blood collected for analysis

Laura Detti, M.D.

PURPOSE: Primary objective: To assess the feasibility and outcomes of male fertility preservation by sperm freezing prior to starting treatment requiring alkylating agents and/or total body irradiation.

Secondary objective: To assess pre- and post-treatment sperm production and hormonal status by measurement of serum anti-mullerian hormone (AMH), inhibin-B, follicle stimulating hormone (FSH), luteinizing hormone (LH), testosterone, and androstendione.

RATIONALE: In June 2006, the American Society of Clinical Oncology published a series of recommendations on fertility preservation for patients with cancer, concluding that "To preserve the full range of options, fertility preservation, approaches should be considered as early as possible during treatment planning". These guidelines reflect the greater attention that has been given in recent years to the fertility complications that can occur as a result of cancer treatment (eg, chemotherapies and radiation).

Different cancer treatments such as cytotoxic therapy can lead to azoospermia and sterility for an unknown period. Whether the type of cancer significantly affects semen quality or not is under debate. In some studies, semen quality of cancer patients did not differ significantly from those without, but other studies have indicated a significant decrease in sperm quality in some malignancies such as testicular cancer and Hodgkin. Fertility and reproductive function are the principal concerns in 80% of successfully treated men with cancer. Although cancer survivors can become parents by adoption or gamete donation, most would prefer to have biologic parenthood and biologically related children.

POPULATION: Adult and post-pubertal males, 13 years of age or older, presenting to our clinic because diagnosed with cancer, who wish to preserve their future fertility. If minors, parents or guardians have to give consent to the procedure while the boys give their assent.

DESIGN: This is a prospective observational cohort study.

PROCEDURES: Subject Recruitment and Screening Subjects will be recruited by referral from the Memphis area cancer centers and physicians whose patients express the desire to have pre-treatment sperm cryopreservation. Minors will be recruited by referral from the St. Jude Children's Research Hospital (SJCRH) and Methodist-Le Bonheur physicians. These subjects will undergo an informed consent process in accordance with University of Tennessee Health Science Center and SJCRH Institutional Review Board. If the five years of storage are up before subjects are ready to claim it, it will be their responsibility to keep the account open by paying a fee of about $300.00 per any additional year in storage. If they withdraw from the study before the five years are up, they will be free to claim the sperm from storage or to leave it there until the five years are up. Afterwards, they will be responsible for the annual fees.

Long term Semen Freezing :

After freezing, sperm samples will be sent to FairFax Cryobank in Austin, Texas for long-term storage. A storage agreement plan has been pre-arranged with FairFax and University of Tennessee Medical Group.

Follow-up clinical information will be collected only when patients return for fertility treatment, if coming to our facility.

No follow-up evaluation will be performed if the patients decide to have their specimens shipped to their new hometown or fertility clinic. However, patients will be asked to contact the investigators regarding their serum/tissue sample use and fertility outcomes. If no contact in this regard is made, patients will be re-contacted by the investigators once every year, if at that time they are 18 years old, or older, and if the five-year storage has expired.

Subject who express the desire to have pre-treatment sperm cryopreservation. These subjects will undergo an informed consent process. If the five years of storage are up before subjects are ready to claim it, it will be their responsibility to keep the account open by paying a fee of about $300.00 per any additional year in storage. If they withdraw from the study before the five years are up, they will be free to claim the sperm from storage or to leave it there until the five years are up. Afterwards, they will be responsible for the annual fees.

Long term Semen Freezing :

After freezing, sperm samples will be sent to FairFax Cryobank in Austin, Texas for long-term storage. A storage agreement plan has been pre-arranged with FairFax and UTMG.

Male Fertility and Sperm Cryopreservation

Male Fertility Pre- and Post- Radiation and Chemotherapy, and Sperm Preservation

•Semen Collection during an office visit. If no sample is able to be collected at that time, the visit may be rescheduled for another day. Also, 2 tablespoons of blood will be drawn from the arm by needle stick for hormonal blood tests. Information such as age, weight, and height, and medical history such as previous health problems will be copied from the medical record.

Semen Collection during an office visit. If no sample is able to be collected at that time, the visit may be rescheduled for another day. Also, 2 tablespoons of blood will be drawn from the arm by needle stick for hormonal blood tests. Information such as age, weight, and height, and medical history such as previous health problems will be copied from the medical record.

Semen will be frozen following existing freezing protocols. Fifty microliters (50 mL), each specimen, will be stored in formalin for later immunohistochemical examination. Fifty mLs will be frozen for metabolite, protein, and messenger Ribonucleic Acid (mRNA) analyses. These analyses will allow us to understand which sperm function is altered by cancer treatment and possibly identify protective measures to prevent such damage. Analyses will be conducted for all samples in the laboratory of the University of Tennessee Center for Reproductive Medicine at the University of Tennessee Health Science Center. This will allow us to have the same reference ranges for each of the different parameters measured and have a homogeneous evaluation of the results. The sperm specimens will be kept in the laboratory until analyzed and/or until completion of the research study.

Serum hormones levels of all samples from thawed serum samples will be analyzed in a central laboratory (LabCorp).

Semen will be frozen following existing freezing protocols. Fifty mLs of each specimen will be stored in formalin for later immunohistochemical examination. Another 50 mLs will be frozen for metabolite, protein, and messenger Ribo Nucleic Acid analyses. These analyses will allow us to understand which sperm function is altered by cancer treatment and possibly identify protective measures to prevent such damage. Analyses will be conducted for all samples in the laboratory of the University of Tennessee Center for Reproductive Medicine at the University of Tennessee Health Science Center. This will allow us to have the same reference ranges for each of the different parameters measured and have a homogeneous evaluation of the results. The sperm specimens will be kept in the laboratory until analyzed and/or until completion of the research study.

Serum levels of the various hormones will be evaluated for all samples from thawed serum samples in a central laboratory (LabCorp).

University of Tennessee

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infertility

Infertility, Male

Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.

Semen collection and analysis

Rachel Neelley

Kyle Orwig, PhD

This study will determine the short-term effects of chemotherapy on sperm DNA.The study involves the collection of semen sample through ejaculation prior to initiation of chemotherapy and up to three time points after initiation of chemotherapy.

While medical advances in the area of cancer treatment have successfully improved the overall detection and treatment of many cancers affecting men and women alike, these very treatment modalities can adversely affect their reproductive capacity.

Certain types of chemotherapy, such as alkylating agents, are notorious for placing patients at high risk for infertility. For men, the best recommendation for patients undergoing such therapy is to cryopreserve semen prior to initiation of chemotherapy. Unfortunately, this may not always occur. Some patients have been noted to present to discuss fertility preservation options after completing their first cycle of chemotherapy. In this situation, they will most likely still have sperm which was produced prior to chemotherapy that can be collected even if the stem cells producing the sperm have been damaged or destroyed. However, there are no national guidelines addressing this particular situation. Typically, physicians may advise men to avoid conception anywhere from three months to two years after the final dose of chemotherapy to ensure all exposed germ cells have passed through and only newly formed germ cells remain.

It is crucial to further assess the effects of chemotherapeutic agents on male germ cells in the short window of time between exposure and potential sterility. If a safe time frame could be determined to collect sperm after a single dose of chemotherapy, then these men could be given a second chance to retain their fertility potential.

Short Term Genetic Effects of Chemotherapy on Male Germ Cells

Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?	NCT04487639	Sperm Preservat... Fertility Cryopreservatio...	SARS-CoV-2 rese...	18 Years - 60 Years	University Hospital, Clermont-Ferrand
Male Fertility and Sperm Cryopreservation	NCT02431000	Fertility SPERM Cancer	Sperm and blood...	13 Years -	University of Tennessee
Short Term Genetic Effects of Chemotherapy on Male Germ Cells	NCT02975245	Cancer	Semen collectio...	18 Years - 50 Years	University of Pittsburgh
Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?	NCT04487639	Sperm Preservat... Fertility Cryopreservatio...	SARS-CoV-2 rese...	18 Years - 60 Years	University Hospital, Clermont-Ferrand

Spots Global Cancer Trial Database for sperm

Every month we try and update this database with for sperm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sperm

Every month we try and update this database with for sperm cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sperm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.