Investigation of Embryoscopy in Recurrent Pregnancy Loss

Not Applicable

Completed

• Conditions: Recurrent Miscarriage
• Interventions: Device: Hysteroscope

• Registration Number: NCT00589446
• Lead Sponsor: Sheba Medical Center

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:-

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-09
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-28
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Hysteroscope	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.

Primary Outcome Measures

Name	Time	Method
To test the value of embryoscopy in women with missed abortions after recurrent miscarriages	Yearly

Secondary Outcome Measures

Name	Time	Method
Whether embryoscopy allows the diagnosis of structural anomalies	Annual
Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.	Annual

Trial Locations

Locations (2)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Herzlia Medical Center; 🇮🇱 Herzliya, Israel