NCT00589446

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. 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. 2.Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

Enrollment Period

3 years

First QC Date

December 27, 2007

Last Update Submit

June 28, 2009

Conditions

Recurrent Miscarriage

Keywords

Embryoscopyrecurrent miscarriagemissed abortionStructural anomalies in recurrent miscarriageEmbryoscopically directed biopsy for karyotyping

Outcome Measures

Primary Outcomes (1)

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

    Yearly

Secondary Outcomes (2)

  • Whether embryoscopy allows the diagnosis of structural anomalies

    Annual

  • Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.

    Annual

Study Arms (1)

1

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.

Device: Hysteroscope

Interventions

HysteroscopeDEVICE

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

1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herzlia Medical Center

Herzliya, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related Publications (3)

  • 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.

    PMID: 12871891BACKGROUND

  • 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.

    PMID: 14607585RESULT

  • Philipp T, Kalousek DK. Transcervical embryoscopy in missed abortion. J Assist Reprod Genet. 2001 May;18(5):285-90. doi: 10.1023/a:1016666301481.

    PMID: 11464580RESULT

MeSH Terms

Conditions

Abortion, HabitualAbortion, Missed

Interventions

Hysteroscopes

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Howard JA Carp, MB BS. FRCOG

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 27, 2007

First Posted

January 9, 2008

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

IL(2)