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.
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
- Conditions the study is for
- Infertility, Sub-fertility, Papillomavirus Infections
- 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
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:
- To study the alterations of sperm present in infertile men according to the presence of HPV in semen.
- Identify the specific HPV genotypes involved.
- To study a potential link between HPV and embryonic characteristics (as classified by Giorgetti)
- To study a potential link between HPV and survival of the conceptus: products of miscarriage or stillbirth, duration of pregnancy, birth weight.
- To study a potential link between HPV and fetal malformations.
- Conditions
- Infertility, Sub-fertility, Papillomavirus Infections
- 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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
HPV test for participating women (cervicovaginal sample): positive/negative
Measured: baseline (day 0)
HPV test for participating men (sperm sample): positive/negative
Measured: baseline (day 0)
Birth of a living, viable child (yes/no)
Measured: end of pregnancy (expected maximum of 9 months)
type of medically assisted procreation used
Measured: baseline (day 0)
Secondary outcomes (17)
HPV genotypes found
Measured: baseline (day 0)
Description of spermogram anomalies
Measured: baseline (day 0)
Embryo score according to Giorgetti et al 1995
Measured: Embryo transfer (baseline, day 0)
Blastocyte score according to Gardner & Schoolcraft 1999
Measured: Embryo transfer (baseline, day 0)
Percentage of implantable embryos
Measured: Baseline (day 0)
BHCG test
Beta HCG - Human Chorionic Gonadotropin (pregnancy test)
Measured: Days 13 to 15 after embryo transfer
Pregnancy confirmed via ultrasound, yes/no
Measured: 5 weeks
Pregnancy confirmed via ultrasound, yes/no
Measured: 12 weeks
Spontaneous miscarriage before 3 months, yes/no
Measured: 3 months
Spontaneous miscarriage after 3 months, yes/no
Measured: end of pregnancy (expected maximum of 9 months)
Spontaneous miscarriage, yes/no
Measured: end of pregnancy (expected maximum of 9 months)
Histological and HPV testing on miscarriage samplings
Measured: end of pregnancy (expected maximum of 9 months)
Days of gestation
Measured: end of pregnancy (expected maximum of 9 months)
Appearance of fetal malformations (yes/no)
Measured: end of pregnancy (expected maximum of 9 months)
HPV testing on placenta (positive/negative + genotype)
Measured: end of pregnancy (expected maximum of 9 months)
Schieve classification according to weeks of gestation and weight of baby
Measured: end of pregnancy (expected maximum of 9 months)
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.
- First posted10 Jul 2013 (estimated)
- Study startMay 2014
- Primary completion23 Oct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Droupy, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Infection by Human Papillomavirus (HPV) in the Success Rate of Pregnancies Achieved Via Medically Assisted Procreation
- ClinicalTrials.gov ID
- NCT01894425
- Acronym / sponsor ID
- PAPILLO-PMA / AOI/2012/SD-01
- Conditions
- Infertility, Sub-fertility, Papillomavirus Infections
- Keywords
- Medically assisted procreation, Assisted reproductive technology, Human papilloma virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 23 Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The secondary objectives of this study are:
- To study the alterations of sperm present in infertile men according to the presence of HPV in semen.
- Identify the specific HPV genotypes involved.
- To study a potential link between HPV and embryonic characteristics (as classified by Giorgetti)
- To study a potential link between HPV and survival of the conceptus: products of miscarriage or stillbirth, duration of pregnancy, birth weight.
- To study a potential link between HPV and fetal malformations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of couples under care for infertility in the participating centers. Gamete donations are not included.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
17 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Droupy, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
4 sites in 1 country: see every site and its status.
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?
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.