Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 23, 2016

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.

Arms, Groups and Cohorts

  • Study population
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
    • Beta HCG – Human Chorionic Gonadotropin (pregnancy test)
  • 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)

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nīmes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stéphane Droupy, MD, PhD, Study Director, Centre Hospitalier Universitaire de Nîmes

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