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

Medical Termination of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02171845
• Other study ID #: FAUQUE ANR 2011
• Status: Recruiting
• Start date: January 29, 2014
• Est. completion date: January 2027

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Patricia FAUQUE
• Phone: 3.80.29.50.31
• Email: patricia.fauque[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 10 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Medical Termination of Pregnancy
• Voluntary Termination of Pregnancy

Intervention

Other:
• surgical biopsies

Locations

Country	Name	City	State
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spatiotemporal analysis piARN way: RT qPCR, Small RNA Seq, and immunoprecipitation of proteins PIWI		Baselines
Primary	Spatio-temporal analysis of the activity of TEs by RT-qPCR and immunostaining		Baselines
Secondary	Promoter methylation profile by pyrosequencing		Baselines