Investigation of Embryoscopy in Recurrent Pregnancy Loss
NCT ID: NCT00589446
Last Updated: 2009-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2006-01-31
2009-01-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Confirmation of missed abortion by ultrasound
* At least 5 1/2 weeks of gestation
* D \& C is clinically indicated
Exclusion Criteria
* Less than two consecutive miscarriages.
* If D \& C is not clinically indicated
FEMALE
No
Sponsors
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Herzliya Medical Center
OTHER
Sheba Medical Center
OTHER_GOV
Responsible Party
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Sheba Medical Center
Principal Investigators
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Howard JA Carp, MB BS. FRCOG
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Herzlia Medical Center
Herzliya, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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References
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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.
Other Identifiers
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SHEBA-05-3804-HC-CTIL
Identifier Type: -
Identifier Source: org_study_id