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Investigation of Embryoscopy in Recurrent Pregnancy Loss

Primary Purpose

Recurrent Miscarriage

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hysteroscope
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Recurrent Miscarriage focused on measuring Embryoscopy, recurrent miscarriage, missed abortion, Structural anomalies in recurrent miscarriage, Embryoscopically directed biopsy for karyotyping

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Herzlia Medical Center
  • Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

To test the value of embryoscopy in women with missed abortions after recurrent miscarriages

Secondary Outcome Measures

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

Full Information

First Posted
December 27, 2007
Last Updated
June 28, 2009
Sponsor
Sheba Medical Center
Collaborators
Herzliya Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00589446
Brief Title
Investigation of Embryoscopy in Recurrent Pregnancy Loss
Official Title
Investigation of Embryoscopy in Recurrent Pregnancy Loss
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center
Collaborators
Herzliya Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Miscarriage
Keywords
Embryoscopy, recurrent miscarriage, missed abortion, Structural anomalies in recurrent miscarriage, Embryoscopically directed biopsy for karyotyping

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hysteroscope
Intervention Description
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
Primary Outcome Measure Information:
Title
To test the value of embryoscopy in women with missed abortions after recurrent miscarriages
Time Frame
Yearly
Secondary Outcome Measure Information:
Title
Whether embryoscopy allows the diagnosis of structural anomalies
Time Frame
Annual
Title
Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.
Time Frame
Annual

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard JA Carp, MB BS. FRCOG
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzlia Medical Center
City
Herzliya
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
12871891
Citation
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.
Results Reference
background
PubMed Identifier
14607585
Citation
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.
Results Reference
result
PubMed Identifier
11464580
Citation
Philipp T, Kalousek DK. Transcervical embryoscopy in missed abortion. J Assist Reprod Genet. 2001 May;18(5):285-90. doi: 10.1023/a:1016666301481.
Results Reference
result

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Investigation of Embryoscopy in Recurrent Pregnancy Loss

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