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Recruiting NCT02171845

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

Observational Medical Termination of Pregnancy Voluntary Termination of Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: surgical biopsies.
Who it may be relevant to
Registry conditions: Medical Termination of Pregnancy, Voluntary Termination of Pregnancy. Basic parameters: 10 Weeks — 37 Weeks · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other surgical biopsies

Primary outcome measures

  • Spatio-temporal analysis of the activity of TEs by RT-qPCR and immunostaining [Time frame: Baselines]
Secondary outcome measures (1)
  • Promoter methylation profile by pyrosequencing [Time frame: Baselines]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHU de DIJON — Dijon

Identifiers

NCT: NCT02171845 · FAUQUE ANR 2011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗