Mechanisms and Factors Responsible for the Inhibition of Transposons During Fetal Gonad Development in Humans

July 7, 2022 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Foetus
Other: surgical biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spatio-temporal analysis of the activity of TEs by RT-qPCR and immunostaining
Time Frame: Baselines
Baselines

Secondary Outcome Measures

Outcome Measure
Time Frame
Promoter methylation profile by pyrosequencing
Time Frame: Baselines
Baselines

Other Outcome Measures

Outcome Measure
Time Frame
Spatiotemporal analysis piARN way: RT qPCR, Small RNA Seq, and immunoprecipitation of proteins PIWI
Time Frame: Baselines
Baselines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2014

Primary Completion (Anticipated)

January 1, 2027

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAUQUE ANR 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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