Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility Sub-fertility Papillomavirus Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No