Clinical trial NCT01894425: Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation
Official title: Study of the Role of Infection by Human Papillomavirus (HPV) in the Success Rate of Pregnancies Achieved Via Medically Assisted Procreation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Sub-fertility
Papillomavirus Infections
Keywords: Medically assisted procreation
Assisted reproductive technology
Human papilloma virus
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of couples under care for infertility in the participating centers. Gamete donations are not included.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: HPV test for participating women (cervicovaginal sample): positive/negative
timeFrame: baseline (day 0)
measure: HPV test for participating men (sperm sample): positive/negative
timeFrame: baseline (day 0)
measure: Birth of a living, viable child (yes/no)
timeFrame: end of pregnancy (expected maximum of 9 months)
measure: type of medically assisted procreation used
timeFrame: baseline (day 0)
Secondary outcomes:
measure: HPV genotypes found
timeFrame: baseline (day 0)
measure: Description of spermogram anomalies
timeFrame: baseline (day 0)
measure: Embryo score according to Giorgetti et al 1995
timeFrame: Embryo transfer (baseline, day 0)
measure: Blastocyte score according to Gardner & Schoolcraft 1999
timeFrame: Embryo transfer (baseline, day 0)
measure: Percentage of implantable embryos
timeFrame: Baseline (day 0)
measure: BHCG test
timeFrame: Days 13 to 15 after embryo transfer
measure: Pregnancy confirmed via ultrasound, yes/no
timeFrame: 5 weeks
measure: Pregnancy confirmed via ultrasound, yes/no
timeFrame: 12 weeks
measure: Spontaneous miscarriage before 3 months, yes/no
timeFrame: 3 months
measure: Spontaneous miscarriage after 3 months, yes/no
timeFrame: end of pregnancy (expected maximum of 9 months)
measure: Spontaneous miscarriage, yes/no
timeFrame: end of pregnancy (expected maximum of 9 months)
measure: Histological and HPV testing on miscarriage samplings
timeFrame: end of pregnancy (expected maximum of 9 months)
measure: Days of gestation
timeFrame: end of pregnancy (expected maximum of 9 months)
measure: Appearance of fetal malformations (yes/no)
timeFrame: end of pregnancy (expected maximum of 9 months)
measure: HPV testing on placenta (positive/negative + genotype)
timeFrame: end of pregnancy (expected maximum of 9 months)
measure: Schieve classification according to weeks of gestation and weight of baby
timeFrame: end of pregnancy (expected maximum of 9 months)
measure: weight of baby at birth / days of gestation (g/day)
timeFrame: end of pregnancy (expected maximum of 9 months)
Other outcomes:
Locations:
city: Montpellier cedex 5
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Stéphane Droupy, MD, PhD
role: STUDY_DIRECTOR
References: