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Implantation Test for Endometrial Receptivity

NCT03442335 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-11-04

No results posted yet for this study

Summary

Background Miscarriage is the most frequent complication of pregnancy and represents the spontaneous loss of the embryo or foetus before it is able to survive independently (24 weeks of gestation). It affects up to 50% of pregnancies with the vast majority (80%) occurring at pre-clinical stage before the woman recognises the pregnancy. Up to 5% of couples suffer recurrent miscarriage defined as 2-3 or more miscarriages leading to physical, emotional and financial consequences for couples, doctors and medical systems.

Different maternal health problems (thyroid disease, sticky blood, autoimmune disease, anatomical anomalies of the womb) and embryo defects may be responsible for some of the miscarriages; however, more than 50% of the occurrences have no identifiable cause based on the current diagnostic tests.

Aim The aim of the present research proposal is to understand the role of the lining of the womb in miscarriage and to explore the development of a potential implantation test that is cost-effective and may be implemented in clinical practice.

Methods Over a period of two years, women who suffered recurrent miscarriage will be approached in the advanced miscarriage clinic at Birmingham Women's Hospital during their routine appointment. Participants will be invited to participate by undergoing chromohysteroscopy and/or a biopsy from the lining of the womb during an outpatient appointment.

Chromohysteroscopy is based on a routine hysteroscopy which involves visualising the inside of the womb using a narrow telescope passed through the neck of the womb (cervix). "Chromo" comes from the fact that an iodine based dye will be injected to increase the power of the test.

The biopsy will be taken using a narrow plastic tube passed through the cervix. It is a standard diagnostic test for women with abnormal bleeding. As part of the present research, different cells and molecules will be analysed from the biopsy sample.

Conditions

  • Pregnancy Loss
  • Miscarriage

Interventions

DIAGNOSTIC_TEST

Chromohysteroscopy

Standard hysteroscopy followed by injection of a dye, in this case iodine.

DIAGNOSTIC_TEST

Endometrial biopsy (Pipelle)

A narrow plastic tube (Pipelle) is passed through the cervix to aspirate a sample of endometrial tissue.

Sponsors & Collaborators

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Laurentiu Craciunas · Tommy's National Centre for Miscarriage Research

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2019-04-30
Completion
2022-10-31

Countries

  • United Kingdom

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 NCT03442335 on ClinicalTrials.gov