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Investigation of Embryoscopy in Recurrent Pregnancy Loss

This study has been completed.
Sponsor:
Collaborator:
Herzliya Medical Center
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00589446
First received: December 27, 2007
Last updated: June 28, 2009
Last verified: June 2009
History of Changes
  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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Investigation of Embryoscopy in Recurrent Pregnancy Loss

Resource links provided by NLM:

MedlinePlus related topics: Miscarriage
U.S. FDA Resources

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
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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

Locations
Israel
Herzlia Medical Center
Herzliya, Israel
Sheba Medical Center
Tel Hashomer, Israel, 52621
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: Prof. Howard Carp, MB, BS. FRCOG (Principal Investigator), Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00589446     History of Changes
Other Study ID Numbers: SHEBA-05-3804-HC-CTIL
Study First Received: December 27, 2007
Last Updated: June 28, 2009
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

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications

ClinicalTrials.gov processed this record on May 16, 2013