Investigation of Embryoscopy in Recurrent Pregnancy Loss

Recurrent Miscarriage Clinical Trial

Official title:

Investigation of Embryoscopy in Recurrent Pregnancy Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589446
• Other study ID #: SHEBA-05-3804-HC-CTIL
• Status: Completed
• Phase: N/A
• First received: December 27, 2007
• Last updated: June 28, 2009
• Start date: January 2006
• Est. completion date: January 2009

Study information

• Verified date: June 2009
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrent Miscarriage

Intervention

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

Locations

Country	Name	City	State
Israel	Herzlia Medical Center	Herzliya
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Herzliya Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Ferro J, Martínez MC, Lara C, Pellicer A, Remohí J, Serra V. Improved accuracy of hysteroembryoscopic biopsies for karyotyping early missed abortions. Fertil Steril. 2003 Nov;80(5):1260-4. — View Citation

Philipp T, Kalousek DK. Transcervical embryoscopy in missed abortion. J Assist Reprod Genet. 2001 May;18(5):285-90. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the value of embryoscopy in women with missed abortions after recurrent miscarriages		Yearly	No
Secondary	Whether embryoscopy allows the diagnosis of structural anomalies		Annual	No
Secondary	Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.		Annual	No