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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01337-34 | Other Identifier | AFSSAPS |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. At the present time, no recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP) procedures. The main objective of this prospective multicentric cohort study is to evaluate the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP, (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the correlation between HPV and male infertility and (4) the correlation between HPV and success rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV vaccination policy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population of couples candidate for MAP program | Other | MAP = medically assisted procreation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systematic HPV DNA assay in semen and cervicovaginal scrape | Other | Screening of HPV status at the genital level of males enrolled in MAP program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of HPV DNA on a swab sampled in the throat of newborns from one or two parents detected positive for HPV in semen and/or cervicovaginal scrape | at birth |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of HPV DNA in seminal fractions: seminal plasma, sperm cells dedicated to MAP | At the time of enrollment, during MAP procedures and at birth (in case of) | |
| Quantitative et qualitative parameters of spermogram analysis: volume of the ejaculate, number, mobility and morphology of sperm cells according to WHO criteria) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas BOURLET, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HĂ´pital Jean VERDIER | Bondy | 93140 | France | |||
| CHU de BORDEAUX |
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| Systematic HPV DNA cervicovaginal scrape | Other | Screening of HPV status at the genital level of females enrolled in MAP program. |
|
| systematic HPV Status in newborns in case of pregnancy | Other |
|
| At the time of enrollment, during MAP procedures and at birth (in case of) |
| Genotype of HPV | At the time of enrollment, during MAP procedures and at birth (in case of) |
| Presence of HPV DNA in ovocytes samples and in embryo culture media | At the time of enrollment, during MAP procedures and at birth (in case of) |
| Quantitative and qualitative parameters of MAP procedures: fertilization rate, number of ovocytes, number of embryos… | At the time of enrollment, during MAP procedures and at birth (in case of) |
| Bordeaux |
| 33000 |
| France |
| CHU de CLERMONT-FERRAND | Clermont-Ferrand | 63000 | France |
| HĂ´pital BICHAT | Paris | 75018 | France |
| CHU de SAINT-ETIENNE | Saint-Etienne | 42055 | France |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D012639 | Seeds |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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