Clinical Trials Directory

Trials / Completed

CompletedNCT00589446

Investigation of Embryoscopy in Recurrent Pregnancy Loss

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Sheba Medical Center · Other Government
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

The purpose is to test the value of embryoscopy in women with missed abortions after recurrent miscarriages (at least two previous miscarriages) in the past. This project will assess two functions of embryoscopy:- 1. Whether embryoscopy allows the diagnosis of structural anomalies (disorganized embryos). This is a fetal cause of embryo loss which cannot be diagnosed by other means. 2. Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping. However, it may be that embryoscopy will be found to have no advantage.

Detailed description

In this project, embryoscopy will be evaluated in women with missed abortions (pregnancies which have ceased developing and in which the embryo is dead), after at least two previous (recurrent) miscarriages. The procedure will have two main purposes:- To allow the diagnosis of structural anomalies (disorganized embryos), and to allow an accurate biopsy of embryonic tissue for karyotyping. Hence, this procedure will lead to a more accurate diagnosis of the cause of recurrent miscarriage. After confirmation of missed abortion by ultrasound, dilatation and curettage (D\&C) is normally performed under general anesthetic to evacuate the uterus in missed abortions. In this project embryoscopy will be added to the standard D\&C. An 8mm hysteroscope with irrigation channel and 300 view will be used with continuous saline flow. The embryo will be visualized, and the findings recorded. Biopsies will be taken for chromosomal analysis from the embryo and the placental villi. Embryoscopy will be performed with a hysteroscope which is in normal clinical use for investigating the uterine cavity, but for a slightly different indication. The first stage will be a pilot study on 20 patients to judge the value of embryoscopy.

Conditions

Interventions

TypeNameDescription
DEVICEHysteroscopeAn 8mm hysteroscope with irrigation channel and 30 degree view will be inserted into the uterus prior to curettage in cases of recurrent missed abortion

Timeline

Start date
2006-01-01
Primary completion
2009-01-01
Completion
2009-01-01
First posted
2008-01-09
Last updated
2009-06-30

Locations

2 sites across 1 country: Israel

Source: ClinicalTrials.gov record NCT00589446. Inclusion in this directory is not an endorsement.