NCT02328742

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

December 26, 2014

Last Update Submit

January 31, 2017

Conditions

InfertilityAbortion, SpontaneousEmbryo Implantation, Delayed

Outcome Measures

Primary Outcomes (4)

  • Activin A

    Day 0 (day of diagnostic hysteroscopy)

  • Inhibin

    Day 0 (day of diagnostic hysteroscopy)

  • Transforming growth factor beta

    Day 0 (day of diagnostic hysteroscopy)

  • Diagnosis of synechia or other intracavitary pathology

    Day 0 (day of diagnostic hysteroscopy)

Secondary Outcomes (9)

  • Activin A

    1 to 2 months after diagnostic hysteroscopy (day of resection)

  • Inhibin

    1 to 2 months after diagnostic hysteroscopy (day of resection)

  • Transforming growth factor beta

    1 to 2 months after diagnostic hysteroscopy (day of resection)

  • Diagnosis of synechia or other intracavitary pathology

    1 to 2 months after diagnostic hysteroscopy (day of resection)

  • Activin A

    1 to 3 months after resection (day of follow-up hysteroscopy)

  • +4 more secondary outcomes

Study Arms (3)

No intracavitary pathology

During the first diagnostic hysteroscopy, patients in this group are found to not have an intracavitary pathology. (The first 20 such patients will be retained in this group.) Intervention: Hysteroscopy + endometrial biopsy Intervention: Telephone call

Biological: Hysteroscopy + endometrial biopsyOther: Telephone call

Synechia

During the first diagnostic hysteroscopy, patients in this group are found to have synechia. Intervention: Hysteroscopy + endometrial biopsy Intervention: Resection + endometrial biopsy Intervention: Follow-up hysteroscopy + endometrial biopsy Intervention: Telephone call

Biological: Hysteroscopy + endometrial biopsyOther: Telephone callBiological: Resection + endometrial biopsyBiological: Follow-up hysteroscopy + endometrial biopsy

Intracavitary pathology

During the first diagnostic hysteroscopy, patients in this group are found to have an intracavitary pathology. Intervention: Hysteroscopy + endometrial biopsy Intervention: Resection + endometrial biopsy Intervention: Follow-up hysteroscopy + endometrial biopsy Intervention: Telephone call

Biological: Hysteroscopy + endometrial biopsyOther: Telephone callBiological: Resection + endometrial biopsyBiological: Follow-up hysteroscopy + endometrial biopsy

Interventions

Hysteroscopy + endometrial biopsyBIOLOGICAL

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.

Intracavitary pathologyNo intracavitary pathologySynechia
Telephone callOTHER

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

Intracavitary pathologyNo intracavitary pathologySynechia
Resection + endometrial biopsyBIOLOGICAL

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.

Intracavitary pathologySynechia
Follow-up hysteroscopy + endometrial biopsyBIOLOGICAL

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.

Intracavitary pathologySynechia

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population consists of women of childbearing age (≥18 years and \<45 years) requiring a hysteroscopy motivated by an infertility evaluation, failure of embryo implantation after invitro fertilization, repeated miscarriages

You may qualify if:

  • The patient must be given free and informed consent and must have signed the consent form
  • The patient must be affiliated with or beneficiary of a health insurance plan
  • Indication for hysteroscopy associated with one of the following: infertility evaluation, postoperative dysmenorrhea, embryo implantation failure after invitro fertilization, recurrent miscarriages

You may not qualify if:

  • The patient is participating in another study
  • The patient is under judicial protection, guardianship or curatorship
  • The patient refuses to sign the consent
  • It is not possible to correctly inform the patient
  • The patient is postmenopausal
  • Indication of hysteroscopy not associated with exploration of infertility or dysmenorrhea
  • Presence of endometritis objectified via sampling during diagnostic hysteroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut des Biomolécules Max Mousseron

Montpellier, 34093, France

Location

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endometrial biopsies.

MeSH Terms

Conditions

InfertilityAbortion, Spontaneous

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Vincent Letouzey, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2014

First Posted

December 31, 2014

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

May 1, 2018

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

FR(3)