NCT06550531

Brief Summary

The prevalence of the papilloma virus in the general population is 12%. This virus is known to impair male fertility but its impact on female infertility remains uncertain. This is a public health problem since there is a vaccination protocol. Demonstrating the impact of the human papillomavirus on fertility would be an argument in favor of vaccination.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
618

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2022

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2026

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

4 years

First QC Date

March 31, 2022

Last Update Submit

August 9, 2024

Conditions

Human Papilloma VirusInfertility, Female

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate after fresh eSET by HPV status

    A clinical pregancy is the visualisation of a gestational sac inside the uterus after 6 weeks of gestation

    1 year

Secondary Outcomes (2)

  • IVF issues

    1 year

  • Positive HPV rate

    1 year

Eligibility Criteria

Age25 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population study is a population of infertile women who are consulting in our center of Reproduction Médicine in CHU Brest.

You may qualify if:

  • all etiology of infertility AMH \> ou = à 1.1 ng/ml First ou second protocol of IVF between 25 years and 37 years and 11 months

You may not qualify if:

  • Age \< 25 y Age \> ou = 38 y AMH \< 1.1 ng/ml patient under juridic protection rejection of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Sarah BOUEE

CONTACT

02 98 22 39 70sarah.bouee@chu-brest.fr

Anne-Solenn JACAMON

CONTACT

anne-solenn.jacamon@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2022

First Posted

August 13, 2024

Study Start

February 4, 2022

Primary Completion

February 4, 2026

Study Completion

February 4, 2026

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning four years and ending five years following the publication
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR(1)