Clinical trial NCT00589446: Investigation of Embryoscopy in Recurrent Pregnancy Loss
Official title: Investigation of Embryoscopy in Recurrent Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Miscarriage
Keywords: Embryoscopy
recurrent miscarriage
missed abortion
Structural anomalies in recurrent miscarriage
Embryoscopically directed biopsy for karyotyping
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Herzliya Medical Center
First posted: 2008-01-09
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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 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

Primary outcomes:
measure: To test the value of embryoscopy in women with missed abortions after recurrent miscarriages
timeFrame: Yearly
Secondary outcomes:
measure: Whether embryoscopy allows the diagnosis of structural anomalies
timeFrame: Annual
measure: Whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping.
timeFrame: Annual
Other outcomes:
Locations:
city: Herzliya
country: Israel
facility: Herzlia Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Howard JA Carp, MB BS. FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1093/humrep/deg309.
citation: Ferro J, Martinez MC, Lara C, Pellicer A, Remohi J, Serra V. Improved accuracy of hysteroembryoscopic biopsies for karyotyping early missed abortions. Fertil Steril. 2003 Nov;80(5):1260-4. doi: 10.1016/s0015-0282(03)02195-2.
citation: Philipp T, Kalousek DK. Transcervical embryoscopy in missed abortion. J Assist Reprod Genet. 2001 May;18(5):285-90. doi: 10.1023/a:1016666301481.