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OpenTrials
Completed

NCT Number: NCT00589446

Investigation of Embryoscopy in Recurrent Pregnancy Loss

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Herzlia Medical Center, Herzliya, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hysteroscope

Device

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

Primary outcomes

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

    Time frame: Yearly

Secondary outcomes

  1. Whether embryoscopy allows the diagnosis of structural anomalies

    Time frame: Annual

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

    Time frame: Annual

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Herzliya Medical Center

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2008
Registry last updated
Jun 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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