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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Infertility; Sub-fertility; Papillomavirus Infections

Study type: Observational

Funder types: Other

Identifiers

NCT01894425

2013-A00538-37 (Other Identifier)

AOI/2012/SD-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

700 participants in 1 patient group

Study population

Description:

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