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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02171845
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 155.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medical Termination of Pregnancy; Voluntary Termination of Pregnancy	Other: surgical biopsies

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Mechanisms and Factors Responsible for the Inhibition of Transposons During Fetal Gonad Development in Humans
• Actual Study Start Date: Jan 29, 2014
• Anticipated Primary Completion Date: Jan 1, 2027
• Anticipated Study Completion Date: Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Foetus	Other: surgical biopsies

Outcome Measures

Primary Outcome Measures

1. Spatio-temporal analysis of the activity of TEs by RT-qPCR and immunostaining [Baselines]

Secondary Outcome Measures

1. Promoter methylation profile by pyrosequencing [Baselines]

Other Outcome Measures

1. Spatiotemporal analysis piARN way: RT qPCR, Small RNA Seq, and immunoprecipitation of proteins PIWI [Baselines]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Weeks to 37 Weeks
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de DIJON	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT02171845
• Other Study ID Numbers: FAUQUE ANR 2011
• First Posted: Jun 24, 2014
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by Centre Hospitalier Universitaire Dijon: Male foetuses of 10 to 37 weeks

Study Results

No Results Posted as of Jul 8, 2022