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Investigation of Embryoscopy in Recurrent Pregnancy Loss
This study is currently recruiting participants.
Verified by Sheba Medical Center, December 2007
First Received: December 27, 2007   Last Updated: January 8, 2008   History of Changes
Sponsors and Collaborators: Sheba Medical Center
Herzliya Medical Center
Information provided by: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00589446
  Purpose

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.


Condition Intervention
Recurrent Miscarriage
Device: Hysteroscope

MedlinePlus related topics: Pregnancy Loss
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title: Investigation of Embryoscopy in Recurrent Pregnancy Loss

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • To test the value of embryoscopy in women with missed abortions after recurrent miscarriages [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Whether embryoscopy allows the diagnosis of structural anomalies [ Time Frame: Annual ] [ Designated as safety issue: No ]
  • Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping. [ Time Frame: Annual ] [ Designated as safety issue: No ]

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
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
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589446

Contacts
Contact: Howard J.A. Carp, M.B., B.S. FRCOG 972-52-6667021 carp@netvision.net.il

Locations
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    
Sponsors and Collaborators
Sheba Medical Center
Herzliya Medical Center
Investigators
Principal Investigator: Howard JA Carp, MB BS. FRCOG Sheba Medical Center, Tel Hashomer, Israel
  More Information

Publications:
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

Keywords provided by Sheba Medical Center:
Embryoscopy
recurrent miscarriage
missed abortion
Structural anomalies in recurrent miscarriage
Embryoscopically directed biopsy for karyotyping

Study placed in the following topic categories:
Pregnancy Complications
Abortion, Missed
Abortion, Habitual
Abortion, Spontaneous
Congenital Abnormalities
Recurrence

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Pregnancy Complications
Abortion, Habitual
Abortion, Spontaneous
Recurrence

ClinicalTrials.gov processed this record on May 07, 2009