Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation

Completed

• Conditions: Infertility; Papillomavirus Infections; Sub-fertility

• Registration Number: NCT01894425
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-10
• Study Start: 2014-05
• Status Verified: 2016-04
• Primary Completion: 2016-10-23
• Study Completion: 2016-12
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV test for participating women (cervicovaginal sample): positive/negative	baseline (day 0)
HPV test for participating men (sperm sample): positive/negative	baseline (day 0)
Birth of a living, viable child (yes/no)	end of pregnancy (expected maximum of 9 months)
type of medically assisted procreation used	baseline (day 0)

Secondary Outcome Measures

Name	Time	Method
HPV genotypes found	baseline (day 0)
Description of spermogram anomalies	baseline (day 0)
Embryo score according to Giorgetti et al 1995	Embryo transfer (baseline, day 0)
Blastocyte score according to Gardner & Schoolcraft 1999	Embryo transfer (baseline, day 0)
Percentage of implantable embryos	Baseline (day 0)
BHCG test	Days 13 to 15 after embryo transfer	Beta HCG - Human Chorionic Gonadotropin (pregnancy test)
Pregnancy confirmed via ultrasound, yes/no	12 weeks
Spontaneous miscarriage before 3 months, yes/no	3 months
Spontaneous miscarriage after 3 months, yes/no	end of pregnancy (expected maximum of 9 months)
Spontaneous miscarriage, yes/no	end of pregnancy (expected maximum of 9 months)
Days of gestation	end of pregnancy (expected maximum of 9 months)
Histological and HPV testing on miscarriage samplings	end of pregnancy (expected maximum of 9 months)
Appearance of fetal malformations (yes/no)	end of pregnancy (expected maximum of 9 months)
Schieve classification according to weeks of gestation and weight of baby	end of pregnancy (expected maximum of 9 months)
HPV testing on placenta (positive/negative + genotype)	end of pregnancy (expected maximum of 9 months)
weight of baby at birth / days of gestation (g/day)	end of pregnancy (expected maximum of 9 months)

Trial Locations

Locations (4)

CHU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France

CHU de Montpellier - Hôpital Saint-Eloi; 🇫🇷 Montpellier cedex 5, France

CHU de Montpellier - Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France