CompletedNot Applicable

Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation

France700 participantsStarted 2014-05

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline (day 0)

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

Timeframe: baseline (day 0)

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

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

type of medically assisted procreation used

Timeframe: baseline (day 0)

Trial details

NCT IDNCT01894425

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-10-23

View on ClinicalTrials.gov More Infertility trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: baseline (day 0)

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

Timeframe: baseline (day 0)

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

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

type of medically assisted procreation used

Timeframe: baseline (day 0)