Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02746588
Other study ID # H-15011157
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2016
Est. completion date January 1, 2019

Study information

Verified date March 2022
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences three or more miscarriages, primarily this happens during the first trimester. These miscarriages often needs medical evacuation or a D & C. Surgery or retained tissue increases the risk of complications as infection and/or adhesions, known as asherman syndrome, which may result in subfertility. Recently chronic infection in the endometrium has been proposed to contribute to the condition, as protocols including treatment with antibiotics have led to birth at term for some of these women. Using the very minimal invasive office hysteroscopy, the investigators aim to describe the uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities in the endometrium and chromic infection.


Description:

The Unit for Recurrent Pregnancy-loss at Rigshospitalet treats about 300 of couples with recurrent miscarriages a year. Together with the current examination program, the investigators plan to describe the uterine cavity according to abnormalities as septa, adhesions and further the condition for the endometrium regarding infection and hormone receptors. This description will include descriptive office hysteroscopy with biopsies for histologic - and immunohistochemically examinations.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Correctly diagnosed with recurrent miscarriages Exclusion Criteria: - Known course of the condition

Study Design


Intervention

Other:
Office hysteroscopy
Diagnostic hysteroscopy with biopsy

Locations

Country Name City State
Denmark Hvidovre Hospital, Department of Gynecology and Obstetrics Copenhagen Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of the Uterine Cavity in Patients With Recurrent Miscarriages Observational study describing the uterine cavity in a selected patient group regarding abnormalities 1 year
Primary Description of the Uterine Cavity in Patients With Recurrent Miscarriages Observational study describing the uterine cavity in a selected patient group regarding chronic infection 1 year
See also
  Status Clinical Trial Phase
Completed NCT03156491 - Maternal Embryo Interaction in Recurrent Miscarriages N/A
Completed NCT00180804 - Maternal KIR and Fetal HLA-C Genes in Recurrent Miscarriages