Infertility, Papillomavirus Infections, Sub-fertility
Conditions
Keywords
Medically assisted procreation, Assisted reproductive technology, Human papilloma virus
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Both members of each couple must have given their free and informed consent and signed the consent * Both members of each couple must be members or beneficiaries of a health insurance plan * The patient (woman) is available for follow-up after a possible pregnancy * The patient (woman) is under 43 years of age * The patient (man) is under 60 years of age * Couple consulting for infertility services in the participating reproductive medicine centers
Exclusion criteria
* One or both members of the couple are involved in another study * One or both members of the couple are in an exclusion period determined by a previous study * One or both members of the couple are under judicial protection or under any kind of guardianship * One or both members of the couple refuse to sign the consent * It is impossible to correctly inform one or both members of the couple * The patient (woman) has a contra-indication (or an incompatible combination therapy) for treatment necessary for this study * The source of sperm is a donor (i.e. it is not possible to obtain a sperm sample from the biological father for use in HPV testing).
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of implantable embryos | Baseline (day 0) | — |
| BHCG test | Days 13 to 15 after embryo transfer | Beta HCG - Human Chorionic Gonadotropin (pregnancy test) |
| Pregnancy confirmed via ultrasound, yes/no | 5 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) | — |
| HPV genotypes found | baseline (day 0) | — |
| 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) | — |
| Histological and HPV testing on miscarriage samplings | end of pregnancy (expected maximum of 9 months) | — |
| Description of spermogram anomalies | baseline (day 0) | — |
| Embryo score according to Giorgetti et al 1995 | Embryo transfer (baseline, day 0) | — |
| Blastocyte score according to Gardner & Schoolcraft 1999 | Embryo transfer (baseline, day 0) | — |
Countries
France
Outcome results
None listed