NCT01894425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

July 4, 2013

Last Update Submit

January 30, 2017

Conditions

InfertilitySub-fertilityPapillomavirus Infections

Keywords

Medically assisted procreationAssisted reproductive technologyHuman papilloma virus

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (17)

  • 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)

  • +12 more secondary outcomes

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of couples under care for infertility in the participating centers. Gamete donations are not included.

You may qualify if:

  • 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

You may not qualify if:

  • One or both members of the couple are involved in another 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples collected (semen and cervical smears) will be sent to the Virology Laboratory of the Hôpital St-Eloi, CHU Montpellier, for analysis. After analysis, the remains of viral DNA will be banked for future studies on the Papilloma Virus.

MeSH Terms

Conditions

InfertilityPapillomavirus Infections

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stéphane Droupy, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2013

First Posted

July 10, 2013

Study Start

May 1, 2014

Primary Completion

October 23, 2016

Study Completion

December 1, 2016

Last Updated

January 31, 2017

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)