NCT02171845

Brief Summary

This is a single-centre study over 36 months for the inclusion of 30 patients. The selection and inclusion of patients will take place according to the criterion of Medical Termination of Pregnancy at 4 different gestational ages (8-12 weeks of gestation (WG)), 13-16 WG, 17-23 WG and 25-35 WG. The tissue analysed will principally be the gonads, other somatic tissue will also be systematically harvested in parallel (liver and psoas muscle) for control purposes. The gonads will be subjected to molecular biology analyses destined to quantify the expression of transposons and their inhibitors.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Jan 2014

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 Progress95%
Jan 2014Jan 2027

Study Start

First participant enrolled

January 29, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

12.9 years

First QC Date

June 18, 2014

Last Update Submit

July 7, 2022

Conditions

Medical Termination of PregnancyVoluntary Termination of Pregnancy

Keywords

Male foetuses of 10 to 37 weeks

Outcome Measures

Primary Outcomes (1)

  • Spatio-temporal analysis of the activity of TEs by RT-qPCR and immunostaining

    Baselines

Secondary Outcomes (1)

  • Promoter methylation profile by pyrosequencing

    Baselines

Other Outcomes (1)

  • Spatiotemporal analysis piARN way: RT qPCR, Small RNA Seq, and immunoprecipitation of proteins PIWI

    Baselines

Study Arms (1)

Foetus

Other: surgical biopsies

Interventions

surgical biopsiesOTHER
Foetus

Eligibility Criteria

Age10 Weeks - 37 Weeks
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Male foetuses of 10 to 37 weeks of amenorrhea obtained following medical termination of pregnancy or voluntary termination of pregnancy.

You may qualify if:

  • Couple or mother who has provided written informed consent
  • Foetus between 10 and 37 weeks of amenorrhea (WA)
  • Male foetus
  • Foetus obtained following medical termination of pregnancy or voluntary termination of pregnancy

You may not qualify if:

  • persons without national health insurance cover
  • foetus presenting aneuploidy
  • foetus presenting a malformation of the genital organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

RECRUITING

Central Study Contacts

Patricia FAUQUE

CONTACT

3.80.29.50.31patricia.fauque@chu-dijon.fr

Study Design

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

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 24, 2014

Study Start

January 29, 2014

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations

FR(1)