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.
Study Type
OBSERVATIONAL
Enrollment
700
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
HPV test for participating women (cervicovaginal sample): positive/negative
Time frame: baseline (day 0)
HPV test for participating men (sperm sample): positive/negative
Time frame: baseline (day 0)
Birth of a living, viable child (yes/no)
Time frame: end of pregnancy (expected maximum of 9 months)
type of medically assisted procreation used
Time frame: baseline (day 0)
HPV genotypes found
Time frame: baseline (day 0)
Description of spermogram anomalies
Time frame: baseline (day 0)
Embryo score according to Giorgetti et al 1995
Time frame: Embryo transfer (baseline, day 0)
Blastocyte score according to Gardner & Schoolcraft 1999
Time frame: Embryo transfer (baseline, day 0)
Percentage of implantable embryos
Time frame: Baseline (day 0)
BHCG test
Beta HCG - Human Chorionic Gonadotropin (pregnancy test)
Time frame: Days 13 to 15 after embryo transfer
Pregnancy confirmed via ultrasound, yes/no
Time frame: 5 weeks
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Pregnancy confirmed via ultrasound, yes/no
Time frame: 12 weeks
Spontaneous miscarriage before 3 months, yes/no
Time frame: 3 months
Spontaneous miscarriage after 3 months, yes/no
Time frame: end of pregnancy (expected maximum of 9 months)
Spontaneous miscarriage, yes/no
Time frame: end of pregnancy (expected maximum of 9 months)
Histological and HPV testing on miscarriage samplings
Time frame: end of pregnancy (expected maximum of 9 months)
Days of gestation
Time frame: end of pregnancy (expected maximum of 9 months)
Appearance of fetal malformations (yes/no)
Time frame: end of pregnancy (expected maximum of 9 months)
HPV testing on placenta (positive/negative + genotype)
Time frame: end of pregnancy (expected maximum of 9 months)
Schieve classification according to weeks of gestation and weight of baby
Time frame: end of pregnancy (expected maximum of 9 months)
weight of baby at birth / days of gestation (g/day)
Time frame: end of pregnancy (expected maximum of 9 months)