Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of the Role of Infection by Human Papillomavirus (HPV) in the Success Rate of Pregnancies Achieved Via Medically Assisted Procreation

Conditions
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Infertility, Sub-fertility, Papillomavirus Infections

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medically assisted procreation, Assisted reproductive technology, Human papilloma virus