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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00538-37 | Other Identifier | RCB number |
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The main objective of this study is to investigate the association between the presence of HPV infection in one or both members of infertile/sub-infertile couples and the outcome of pregnancies obtained by assisted reproduction.
The success of assisted medical procreation is defined as achieving a pregnancy resulting in the birth of a living, viable child.
The secondary objectives of this study are:
A. To study the alterations of sperm present in infertile men according to the presence of HPV in semen.
B. Identify the specific HPV genotypes involved.
C. To study a potential link between HPV and embryonic characteristics (as classified by Giorgetti)
D. To study a potential link between HPV and survival of the conceptus: products of miscarriage or stillbirth, duration of pregnancy, birth weight.
E. To study a potential link between HPV and fetal malformations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | The study population consists of couples under care for infertility in the participating centers. Gamete donations are not included. Please see inclusion and exclusion criteria. Intervention: HPV screening for women Intervention: HPV screening for men |
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| Measure | Description | Time Frame |
|---|---|---|
| HPV test for participating women (cervicovaginal sample): positive/negative | baseline (day 0) | |
| HPV test for participating men (sperm sample): positive/negative | baseline (day 0) | |
| Birth of a living, viable child (yes/no) | end of pregnancy (expected maximum of 9 months) | |
| type of medically assisted procreation used | baseline (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| HPV genotypes found | baseline (day 0) | |
| Description of spermogram anomalies | baseline (day 0) | |
| Embryo score according to Giorgetti et al 1995 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of couples under care for infertility in the participating centers. Gamete donations are not included.
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Droupy, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France | |||
| CHU de Montpellier - Hôpital Lapeyronie |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
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Samples collected (semen and cervical smears) will be sent to the Virology Laboratory of the Hôpital St-Eloi, CHU Montpellier, for analysis. After analysis, the remains of viral DNA will be banked for future studies on the Papilloma Virus.
| Embryo transfer (baseline, day 0) |
| Blastocyte score according to Gardner & Schoolcraft 1999 | Embryo transfer (baseline, day 0) |
| Percentage of implantable embryos | Baseline (day 0) |
| BHCG test | Beta HCG - Human Chorionic Gonadotropin (pregnancy test) | Days 13 to 15 after embryo transfer |
| Pregnancy confirmed via ultrasound, yes/no | 5 weeks |
| Pregnancy confirmed via ultrasound, yes/no | 12 weeks |
| Spontaneous miscarriage before 3 months, yes/no | 3 months |
| Spontaneous miscarriage after 3 months, yes/no | end of pregnancy (expected maximum of 9 months) |
| Spontaneous miscarriage, yes/no | end of pregnancy (expected maximum of 9 months) |
| Histological and HPV testing on miscarriage samplings | end of pregnancy (expected maximum of 9 months) |
| Days of gestation | end of pregnancy (expected maximum of 9 months) |
| Appearance of fetal malformations (yes/no) | end of pregnancy (expected maximum of 9 months) |
| HPV testing on placenta (positive/negative + genotype) | end of pregnancy (expected maximum of 9 months) |
| Schieve classification according to weeks of gestation and weight of baby | end of pregnancy (expected maximum of 9 months) |
| weight of baby at birth / days of gestation (g/day) | end of pregnancy (expected maximum of 9 months) |
| Montpellier |
| 34295 |
| France |
| CHU de Montpellier - Hôpital Saint-Eloi | Montpellier | 34295 | France |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |