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InfertilityPAPILLO-PMANCT01894425

Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation

An observational study of Infertility and Sub-fertility, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
How many people
700 participants
Where
4 sitesFrance
Study dates
May 2014to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • CHU de Montpellier - Hôpital Saint-Eloi

    Montpellier, 34295

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: 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.

Read the detailed description

The secondary objectives of this study are:

  1. To study the alterations of sperm present in infertile men according to the presence of HPV in semen.
  2. Identify the specific HPV genotypes involved.
  3. To study a potential link between HPV and embryonic characteristics (as classified by Giorgetti)
  4. To study a potential link between HPV and survival of the conceptus: products of miscarriage or stillbirth, duration of pregnancy, birth weight.
  5. To study a potential link between HPV and fetal malformations.
Keywords
Medically assisted procreation, Assisted reproductive technology, Human papilloma virus
Medical subject headings
Infertility, Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01894425
Study groupRoleWhat they receive
Study populationThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. HPV test for participating women (cervicovaginal sample): positive/negative

    Measured: baseline (day 0)

  2. HPV test for participating men (sperm sample): positive/negative

    Measured: baseline (day 0)

  3. Birth of a living, viable child (yes/no)

    Measured: end of pregnancy (expected maximum of 9 months)

  4. type of medically assisted procreation used

    Measured: baseline (day 0)

Secondary outcomes (17)

  1. HPV genotypes found

    Measured: baseline (day 0)

  2. Description of spermogram anomalies

    Measured: baseline (day 0)

  3. Embryo score according to Giorgetti et al 1995

    Measured: Embryo transfer (baseline, day 0)

  4. Blastocyte score according to Gardner & Schoolcraft 1999

    Measured: Embryo transfer (baseline, day 0)

  5. Percentage of implantable embryos

    Measured: Baseline (day 0)

  6. BHCG test

    Beta HCG - Human Chorionic Gonadotropin (pregnancy test)

    Measured: Days 13 to 15 after embryo transfer

  7. Pregnancy confirmed via ultrasound, yes/no

    Measured: 5 weeks

  8. Pregnancy confirmed via ultrasound, yes/no

    Measured: 12 weeks

  9. Spontaneous miscarriage before 3 months, yes/no

    Measured: 3 months

  10. Spontaneous miscarriage after 3 months, yes/no

    Measured: end of pregnancy (expected maximum of 9 months)

  11. Spontaneous miscarriage, yes/no

    Measured: end of pregnancy (expected maximum of 9 months)

  12. Histological and HPV testing on miscarriage samplings

    Measured: end of pregnancy (expected maximum of 9 months)

  13. Days of gestation

    Measured: end of pregnancy (expected maximum of 9 months)

  14. Appearance of fetal malformations (yes/no)

    Measured: end of pregnancy (expected maximum of 9 months)

  15. HPV testing on placenta (positive/negative + genotype)

    Measured: end of pregnancy (expected maximum of 9 months)

  16. Schieve classification according to weeks of gestation and weight of baby

    Measured: end of pregnancy (expected maximum of 9 months)

  17. weight of baby at birth / days of gestation (g/day)

    Measured: end of pregnancy (expected maximum of 9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2013 (estimated)
  2. Study startMay 2014
  3. Primary completion23 Oct 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01894425
Sponsor's protocol ID
AOI/2012/SD-01
Other IDs
2013-A00538-37
Acronym
PAPILLO-PMA
Status last verified
Apr 2016
First submitted
4 Jul 2013
Last updated
31 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility and Sub-fertility, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HPV test for participating women (cervicovaginal sample): positive/negative (time frame: baseline (day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01894425.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.

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