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Completed

NCT Number: NCT01894425

Human Papillomavirus and Rate of Pregnancy Achieved Via Medically Assisted Procreation

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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Key information

Conditions

Infertility Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Sub-Fertility Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. HPV test for participating women (cervicovaginal sample): positive/negative

    Time frame: baseline (day 0)

  2. HPV test for participating men (sperm sample): positive/negative

    Time frame: baseline (day 0)

  3. Birth of a living, viable child (yes/no)

    Time frame: end of pregnancy (expected maximum of 9 months)

  4. type of medically assisted procreation used

    Time frame: baseline (day 0)

Secondary outcomes

  1. HPV genotypes found

    Time frame: baseline (day 0)

  2. Description of spermogram anomalies

    Time frame: baseline (day 0)

  3. Embryo score according to Giorgetti et al 1995

    Time frame: Embryo transfer (baseline, day 0)

  4. Blastocyte score according to Gardner & Schoolcraft 1999

    Time frame: Embryo transfer (baseline, day 0)

  5. Percentage of implantable embryos

    Time frame: Baseline (day 0)

  6. BHCG test

    Time frame: Days 13 to 15 after embryo transfer

    Beta HCG - Human Chorionic Gonadotropin (pregnancy test)

  7. Pregnancy confirmed via ultrasound, yes/no

    Time frame: 5 weeks

  8. Pregnancy confirmed via ultrasound, yes/no

    Time frame: 12 weeks

  9. Spontaneous miscarriage before 3 months, yes/no

    Time frame: 3 months

  10. Spontaneous miscarriage after 3 months, yes/no

    Time frame: end of pregnancy (expected maximum of 9 months)

  11. Spontaneous miscarriage, yes/no

    Time frame: end of pregnancy (expected maximum of 9 months)

  12. Histological and HPV testing on miscarriage samplings

    Time frame: end of pregnancy (expected maximum of 9 months)

  13. Days of gestation

    Time frame: end of pregnancy (expected maximum of 9 months)

  14. Appearance of fetal malformations (yes/no)

    Time frame: end of pregnancy (expected maximum of 9 months)

  15. HPV testing on placenta (positive/negative + genotype)

    Time frame: end of pregnancy (expected maximum of 9 months)

  16. Schieve classification according to weeks of gestation and weight of baby

    Time frame: end of pregnancy (expected maximum of 9 months)

  17. weight of baby at birth / days of gestation (g/day)

    Time frame: end of pregnancy (expected maximum of 9 months)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: PAPILLO-PMA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2013
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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