Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation (PAPILLO-PMA)

January 30, 2017 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU de Montpellier - Hôpital Lapeyronie
      • Montpellier, France, 34295
        • CHU de Montpellier - Hôpital Arnaud de Villeneuve
      • Montpellier cedex 5, France, 34295
        • CHU de Montpellier - Hôpital Saint-Eloi
      • Nîmes Cedex 9, France, 30029
        • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HPV test for participating women (cervicovaginal sample): positive/negative
Time Frame: baseline (day 0)
baseline (day 0)
HPV test for participating men (sperm sample): positive/negative
Time Frame: baseline (day 0)
baseline (day 0)
Birth of a living, viable child (yes/no)
Time Frame: end of pregnancy (expected maximum of 9 months)
end of pregnancy (expected maximum of 9 months)
type of medically assisted procreation used
Time Frame: baseline (day 0)
baseline (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV genotypes found
Time Frame: baseline (day 0)
baseline (day 0)
Description of spermogram anomalies
Time Frame: baseline (day 0)
baseline (day 0)
Embryo score according to Giorgetti et al 1995
Time Frame: Embryo transfer (baseline, day 0)
Embryo transfer (baseline, day 0)
Blastocyte score according to Gardner & Schoolcraft 1999
Time Frame: Embryo transfer (baseline, day 0)
Embryo transfer (baseline, day 0)
Percentage of implantable embryos
Time Frame: Baseline (day 0)
Baseline (day 0)
BHCG test
Time Frame: Days 13 to 15 after embryo transfer
Beta HCG - Human Chorionic Gonadotropin (pregnancy test)
Days 13 to 15 after embryo transfer
Pregnancy confirmed via ultrasound, yes/no
Time Frame: 5 weeks
5 weeks
Pregnancy confirmed via ultrasound, yes/no
Time Frame: 12 weeks
12 weeks
Spontaneous miscarriage before 3 months, yes/no
Time Frame: 3 months
3 months
Spontaneous miscarriage after 3 months, yes/no
Time Frame: end of pregnancy (expected maximum of 9 months)
end of pregnancy (expected maximum of 9 months)
Spontaneous miscarriage, yes/no
Time Frame: end of pregnancy (expected maximum of 9 months)
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)
end of pregnancy (expected maximum of 9 months)
Days of gestation
Time Frame: end of pregnancy (expected maximum of 9 months)
end of pregnancy (expected maximum of 9 months)
Appearance of fetal malformations (yes/no)
Time Frame: end of pregnancy (expected maximum of 9 months)
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)
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)
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)
end of pregnancy (expected maximum of 9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Stéphane Droupy, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 23, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI/2012/SD-01
  • 2013-A00538-37 (Other Identifier: RCB number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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