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Sponsors and Collaborators: |
Sheba Medical Center Herzliya Medical Center |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00589446 |
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:-
However, it may be that embryoscopy will be found to have no advantage.
Condition | Intervention |
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Recurrent Miscarriage |
Device: Hysteroscope |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Investigation of Embryoscopy in Recurrent Pregnancy Loss |
Estimated Enrollment: | 20 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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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
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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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Howard J.A. Carp, M.B., B.S. FRCOG | 972-52-6667021 | carp@netvision.net.il |
Israel | |
Sheba Medical Center | Recruiting |
Tel Hashomer, Israel, 52621 | |
Contact: Howard JA Carp, MB BS. FRCOG 972-52-6667021 carp@netvision.net.il | |
Principal Investigator: Howard JA Carp, MB BS, FRCOG | |
Herzlia Medical Center | Recruiting |
Herzliya, Israel | |
Contact: Howard JA Carp, MB BS, FRCOG 972-52-6667021 carp@netvision.net.il |
Principal Investigator: | Howard JA Carp, MB BS. FRCOG | Sheba Medical Center, Tel Hashomer, Israel |
Responsible Party: | Sheba Medical Center ( Prof. Howard Carp, MB, BS. FRCOG (Principal Investigator) ) |
Study ID Numbers: | SHEBA-05-3804-HC-CTIL |
Study First Received: | December 27, 2007 |
Last Updated: | January 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00589446 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Embryoscopy recurrent miscarriage missed abortion Structural anomalies in recurrent miscarriage Embryoscopically directed biopsy for karyotyping |
Pregnancy Complications Abortion, Missed Abortion, Habitual |
Abortion, Spontaneous Congenital Abnormalities Recurrence |
Disease Attributes Pathologic Processes Pregnancy Complications |
Abortion, Habitual Abortion, Spontaneous Recurrence |