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Prediction of Preterm Deliveries by Cervical Length Measurement With Embryo Transfer Catheter in ICSI Patients

NCT02059304 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-12-23

No results posted yet for this study

Summary

The aim of this study is to examine the potential value of cervical length (CL) measurement with embryo transfer catheter in the prediction of spontaneous preterm deliveries in intracytoplasmic sperm injection (ICSI) cycles.

Preterm birth is the leading cause of perinatal death and handicap in children. It is clear that ICSI pregnancies are at high risk groupfor preterm delivery (PTD). In singletons there is an estimated two-fold increased risk following ICSI.

CL measurement with ultrasound in mid-trimester (22-24 weeks) is the best method for the prediction of PTD: The shorter the CL, the higher risk of PTD. Recent evidence suggests that at first trimester (11-13 weeks), the risk for PTD is inversely related to CL. It has been shown that the measurement of CL on pregnancy is an effective method for identification of the group at high risk for PTD.

In embryo transfer, catheter is placed the through cervical canal. The method we will use in this study, CL measurement with transfer catheter, will give more precise results than measurement with ultrasound.

No study has been performed to evaluate the prediction of PTD by analyzing measurements of CL, preconceptionally. Our study will be the first in this topic.

There is a certain disadvantage of measuring CL during pregnancy: The effectiveness of prophylactic administrations (progesterone, cervical cerclage etc.) may be inversely related to the gestation at which treatment is initiated. If we know the risk of PTD before gestation, single embryo transfer will be preferred to avoid from multiple pregnancies that also increase the relative risk of PTD, in ICSI pregnancies.

Conditions

  • Preterm Delivery

Interventions

DEVICE

Measurement of cervical length with embryo transfer catheter

Sponsors & Collaborators

  • Acibadem University

    lead OTHER

Principal Investigators

  • Turgut Aydin · Acıbadem Kayseri Hospital

Study Design

Purpose
SCREENING

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-04-30
Completion
2014-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059304 on ClinicalTrials.gov