Overview

This trial is active, not recruiting.

Conditions infertility, sub-fertility, papillomavirus infections
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date May 2014
End date August 2016
Trial size 700 participants
Trial identifier NCT01894425, 2013-A00538-37, AOI/2012/SD-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
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
time frame: Days 13 to 15 after embryo transfer
Pregnancy confirmed via ultrasound, yes/no
time frame: 5 weeks
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)

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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).

Additional Information

Official title Study of the Role of Infection by Human Papillomavirus (HPV) in the Success Rate of Pregnancies Achieved Via Medically Assisted Procreation
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.