Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation

Infertility Clinical Trial

— PAPILLO-PMA  

Official title:

Study of the Role of Infection by Human Papillomavirus (HPV) in the Success Rate of Pregnancies Achieved Via Medically Assisted Procreation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894425
• Other study ID #: AOI/2012/SD-01
• Secondary ID: 2013-A00538-37
• Status: Completed
• Phase: N/A
• First received: July 4, 2013
• Last updated: January 30, 2017
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The success of assisted medical procreation is defined as achieving a pregnancy resulting in the birth of a living, viable child.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 2016
• Est. primary completion date: October 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infection
• Infertility
• Papillomavirus Infections
• Sub-fertility

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU de Montpellier - Hôpital Saint-Eloi	Montpellier cedex 5
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV test for participating women (cervicovaginal sample): positive/negative		baseline (day 0)
Primary	HPV test for participating men (sperm sample): positive/negative		baseline (day 0)
Primary	Birth of a living, viable child (yes/no)		end of pregnancy (expected maximum of 9 months)
Primary	type of medically assisted procreation used		baseline (day 0)
Secondary	HPV genotypes found		baseline (day 0)
Secondary	Description of spermogram anomalies		baseline (day 0)
Secondary	Embryo score according to Giorgetti et al 1995		Embryo transfer (baseline, day 0)
Secondary	Blastocyte score according to Gardner & Schoolcraft 1999		Embryo transfer (baseline, day 0)
Secondary	Percentage of implantable embryos		Baseline (day 0)
Secondary	BHCG test	Beta HCG - Human Chorionic Gonadotropin (pregnancy test)	Days 13 to 15 after embryo transfer
Secondary	Pregnancy confirmed via ultrasound, yes/no		5 weeks
Secondary	Pregnancy confirmed via ultrasound, yes/no		12 weeks
Secondary	Spontaneous miscarriage before 3 months, yes/no		3 months
Secondary	Spontaneous miscarriage after 3 months, yes/no		end of pregnancy (expected maximum of 9 months)
Secondary	Spontaneous miscarriage, yes/no		end of pregnancy (expected maximum of 9 months)
Secondary	Histological and HPV testing on miscarriage samplings		end of pregnancy (expected maximum of 9 months)
Secondary	Days of gestation		end of pregnancy (expected maximum of 9 months)
Secondary	Appearance of fetal malformations (yes/no)		end of pregnancy (expected maximum of 9 months)
Secondary	HPV testing on placenta (positive/negative + genotype)		end of pregnancy (expected maximum of 9 months)
Secondary	Schieve classification according to weeks of gestation and weight of baby		end of pregnancy (expected maximum of 9 months)
Secondary	weight of baby at birth / days of gestation (g/day)		end of pregnancy (expected maximum of 9 months)