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Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.

NCT02328742 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-02-01

No results posted yet for this study

Summary

The main objective of this study is to describe the level of expression of the biological factors involved in the formation of adhesions (Transforming growth factor beta, Activin A, inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another intracavitary disease or no intracavitary disease.

Conditions

  • Infertility
  • Abortion, Spontaneous
  • Embryo Implantation, Delayed

Interventions

BIOLOGICAL

Hysteroscopy + endometrial biopsy

The day of the first diagnostic hysteroscopy an endometrial biopsy is performed (biopsy A1). These biopsies will be used for the evaluation of TGFbeta, Activin A and inhibin. This intervention is required for the observational needs of this study.

OTHER

Telephone call

Patients will be contacted via telephone 6 months after first hysteroscopy. This intervention is required for the observational needs of this study.

BIOLOGICAL

Resection + endometrial biopsy

If patients are found to have synechia or another intracavitary pathology, resection is scheduled 1-2 months later. A second endometrial biopsy is performed at this time. This intervention is required for the observational needs of this study.

BIOLOGICAL

Follow-up hysteroscopy + endometrial biopsy

For patients having had resection, a follow-up hysteroscopy is performed 1 to 3 months later. An endometrial biopsy will be performed at this time. This intervention is required for the observational needs of this study.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Vincent Letouzey, MD · Centre Hospitalier Universitaire de Nîmes

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30
Completion
2018-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02328742 on ClinicalTrials.gov