Investigation of Embryoscopy in Recurrent Pregnancy Loss - Tabular View

Tracking Information

First Received Date ^ICMJE

December 27, 2007

Last Updated Date

June 28, 2009

Start Date ^ICMJE

January 2006

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To test the value of embryoscopy in women with missed abortions after recurrent miscarriages [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00589446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Whether embryoscopy allows the diagnosis of structural anomalies [ Time Frame: Annual ] [ Designated as safety issue: No ]
Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping. [ Time Frame: Annual ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Investigation of Embryoscopy in Recurrent Pregnancy Loss

Official Title ^ICMJE

Investigation of Embryoscopy in Recurrent Pregnancy Loss

Brief 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:-

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.
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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Recurrent Miscarriage

Intervention ^ICMJE

Device: Hysteroscope

Study Arms / Comparison Groups

Experimental: Embryoscopy will be evaluated in women with at least two previous miscarriages, after confirmation of missed abortion by ultrasound. Embryoscopy will only be performed in patients in whom curettage is clinically indicated, and will only be added to the D&C if there is a possibility of visualizing embryonic tissue, i:e. from approximately 5½ weeks onwards when there is an embryonic pole detected on ultrasound.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Recurrent miscarriage, (at least 2 consecutive miscarriages)
Confirmation of missed abortion by ultrasound
At least 5 1/2 weeks of gestation
D & C is clinically indicated

Exclusion Criteria:

Sporadic miscarriages
Less than two consecutive miscarriages.
If D & C is not clinically indicated

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00589446

Responsible Party

Prof. Howard Carp, MB, BS. FRCOG (Principal Investigator), Sheba Medical Center

Study ID Numbers ^ICMJE

SHEBA-05-3804-HC-CTIL

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Herzliya Medical Center

Investigators ^ICMJE

Principal Investigator:

Howard JA Carp, MB BS. FRCOG

Sheba Medical Center, Tel Hashomer, Israel

Information Provided By

Sheba Medical Center

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP