Investigation of Embryoscopy in Recurrent Pregnancy Loss

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Miscarriage
• Intervention / Treatment: Device: Hysteroscope

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Herzliya, Israel
    • Herzlia Medical Center
  • Tel Hashomer, Israel, 52621
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 1; 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.

Device: Hysteroscope; An 8mm hysteroscope with irrigation channel and 30 degree view will be inserted into the uterus prior to curettage in cases of recurrent missed abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To test the value of embryoscopy in women with missed abortions after recurrent miscarriages	Yearly

Secondary Outcome Measures

Outcome Measure	Time Frame
Whether embryoscopy allows the diagnosis of structural anomalies	Annual
Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.	Annual

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Herzliya Medical Center
• Investigators: Principal Investigator: Howard JA Carp, MB BS. FRCOG, Sheba Medical Center

Publications and helpful links

General Publications

• Philipp T, Philipp K, Reiner A, Beer F, Kalousek DK. Embryoscopic and cytogenetic analysis of 233 missed abortions: factors involved in the pathogenesis of developmental defects of early failed pregnancies. Hum Reprod. 2003 Aug;18(8):1724-32. doi: 10.1093/humrep/deg309.
• Ferro J, Martinez MC, Lara C, Pellicer A, Remohi J, Serra V. Improved accuracy of hysteroembryoscopic biopsies for karyotyping early missed abortions. Fertil Steril. 2003 Nov;80(5):1260-4. doi: 10.1016/s0015-0282(03)02195-2.
• Philipp T, Kalousek DK. Transcervical embryoscopy in missed abortion. J Assist Reprod Genet. 2001 May;18(5):285-90. doi: 10.1023/a:1016666301481.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): January 1, 2009

Study Registration Dates

• First Submitted: December 27, 2007
• First Submitted That Met QC Criteria: January 8, 2008
• First Posted (ESTIMATE): January 9, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 30, 2009
• Last Update Submitted That Met QC Criteria: June 28, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: recurrent miscarriage; missed abortion; Embryoscopy; Structural anomalies in recurrent miscarriage; Embryoscopically directed biopsy for karyotyping
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Recurrence; Abortion, Spontaneous; Abortion, Habitual
• Other Study ID Numbers: SHEBA-05-3804-HC-CTIL