Trial record 6 of 57 for:    Open Studies | "Papillomavirus Infections"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01894425
First received: July 4, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition
Infertility
Sub-fertility
Papillomavirus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Role of Infection by Human Papillomavirus (HPV) in the Success Rate of Pregnancies Achieved Via Medically Assisted Procreation

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • HPV test for participating women (cervicovaginal sample): positive/negative [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • HPV test for participating men (sperm sample): positive/negative [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Birth of a living, viable child (yes/no) [ Time Frame: end of pregnancy (expected maximum of 9 months) ] [ Designated as safety issue: No ]
  • type of medically assisted procreation used [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HPV genotypes found [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Description of spermogram anomalies [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Embryo score according to Giorgetti et al 1995 [ Time Frame: Embryo transfer (baseline, day 0) ] [ Designated as safety issue: No ]
  • Blastocyte score according to Gardner & Schoolcraft 1999 [ Time Frame: Embryo transfer (baseline, day 0) ] [ Designated as safety issue: No ]
  • Percentage of implantable embryos [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • BHCG test [ Time Frame: Days 13 to 15 after embryo transfer ] [ Designated as safety issue: No ]
    Beta HCG - Human Chorionic Gonadotropin (pregnancy test)

  • Pregnancy confirmed via ultrasound, yes/no [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Pregnancy confirmed via ultrasound, yes/no [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Spontaneous miscarriage before 3 months, yes/no [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Spontaneous miscarriage after 3 months, yes/no [ Time Frame: end of pregnancy (expected maximum of 9 months) ] [ Designated as safety issue: No ]
  • Spontaneous miscarriage, yes/no [ Time Frame: end of pregnancy (expected maximum of 9 months) ] [ Designated as safety issue: No ]
  • Histological and HPV testing on miscarriage samplings [ Time Frame: end of pregnancy (expected maximum of 9 months) ] [ Designated as safety issue: No ]
  • Days of gestation [ Time Frame: end of pregnancy (expected maximum of 9 months) ] [ Designated as safety issue: No ]
  • Appearance of fetal malformations (yes/no) [ Time Frame: end of pregnancy (expected maximum of 9 months) ] [ Designated as safety issue: No ]
  • HPV testing on placenta (positive/negative + genotype) [ Time Frame: end of pregnancy (expected maximum of 9 months) ] [ Designated as safety issue: No ]
  • Schieve classification according to weeks of gestation and weight of baby [ Time Frame: end of pregnancy (expected maximum of 9 months) ] [ Designated as safety issue: No ]
  • weight of baby at birth / days of gestation (g/day) [ Time Frame: end of pregnancy (expected maximum of 9 months) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples collected (semen and cervical smears) will be sent to the Virology Laboratory of the Hôpital St-Eloi, CHU Montpellier, for analysis. After analysis, the remains of viral DNA will be banked for future studies on the Papilloma Virus.


Estimated Enrollment: 700
Study Start Date: May 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population consists of couples under care for infertility in the participating centers. Gamete donations are not included.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894425

Contacts
Contact: Stéphane Droupy, MD, PhD +33.(0)4.66.68.30.57 stephane.droupy@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Montpellier - Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Sub-Investigator: Hervé Dechaud, MD, PhD         
Principal Investigator: Mathilde Monforte, MD         
Sub-Investigator: Samir Hamamah, MD, PhD         
CHU de Montpellier - Hôpital Lapeyronie Recruiting
Montpellier, France, 34295
Sub-Investigator: Grégoire Poinas, MD         
CHU de Montpellier - Hôpital Saint-Eloi Recruiting
Montpellier cedex 5, France, 34295
Sub-Investigator: Michel Segondy, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Sub-Investigator: Stéphane Droupy, MD,         
Principal Investigator: Albert Sotto, MD, PhD         
Sub-Investigator: Marie-Laure Tailland, MD         
Sub-Investigator: Sylvie Ripart, MD         
Sub-Investigator: Nathalie Rougier, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Stéphane Droupy, MD, PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01894425     History of Changes
Other Study ID Numbers: AOI/2012/SD-01, 2013-A00538-37
Study First Received: July 4, 2013
Last Updated: June 16, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Medically assisted procreation
Assisted reproductive technology
Human papilloma virus

Additional relevant MeSH terms:
Infertility
Papillomavirus Infections
Genital Diseases, Male
Genital Diseases, Female
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on July 09, 2014