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Implantation Test for Endometrial Receptivity

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ClinicalTrials.gov Identifier: NCT03442335
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Birmingham

Brief 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.


Condition or disease Intervention/treatment
Pregnancy Loss Miscarriage Diagnostic Test: Chromohysteroscopy Diagnostic Test: Endometrial biopsy (Pipelle)

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implantation Test for Endometrial Receptivity
Actual Study Start Date : December 12, 2017
Actual Primary Completion Date : April 30, 2019
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Group/Cohort Intervention/treatment
Recurrent miscarriage: 2+ miscarriages
Women who suffered 2 or more unexplained recurrent miscarriages.
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.
Other Name: Endometrial sampling

Extreme recurrent miscarriage: 5+ miscarriages
Women who suffered 5 or more unexplained recurrent miscarriages.
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.
Other Name: Endometrial sampling




Primary Outcome Measures :
  1. Iodine absorption [ Time Frame: 2 years ]
    Iodine interaction with the mid luteal phase endometrium.

  2. Transcriptome profile [ Time Frame: 2 years ]
    Transcriptomics analysis of endometrial samples.

  3. Proteome profile [ Time Frame: 2 years ]
    Proteomics analysis of endometrial samples.

  4. Metabolome profile [ Time Frame: 2 years ]
    Metabolomics analysis of endometrial samples.


Secondary Outcome Measures :
  1. Miscarriage rate [ Time Frame: 5 years ]
    Miscarriage rates in future pregnancies.

  2. Live birth rate [ Time Frame: 5 years ]
    Live birth rates in future pregnancies.


Biospecimen Retention:   Samples With DNA
Endometrial samples taken during the implantation window (mid luteal phase, timed based on LH surge).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women who suffered recurrent miscarriage (2+ miscarriages).
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A cohort of women who suffered unexplained recurrent miscarriage will be sub grouped in two study populations: women who suffered two or more miscarriages and women who suffered five or more miscarriages (extreme recurrent miscarriage cohort). A total of 60 women will be recruited for the study investigations (30 for chromohysteroscopy and 30 for endometrial biopsy).

We will select a very narrow phenotype in order to increase the study's sensitivity and power. Participants will be 18-35 years old, not pregnant and regularly menstruating in order to reduce the age effect on the pregnancy outcome. They will be diagnosed as having unexplained recurrent miscarriage by undertaking the standard miscarriage investigations.

Criteria

Inclusion Criteria:

  • women diagnosed with unexplained recurrent miscarriage (2+ miscarriages with negative standard miscarriage investigations)
  • regular menstrual cycles

Exclusion Criteria:

  • women who have irregular menstrual cycles or those who require fertility treatments
  • any positive finding or health issue that may explain the diagnosis of recurrent miscarriage
  • women who are pregnant at the time of the study investigations
  • women who are participants in other interventional studies or trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442335


Locations
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United Kingdom
Tommy's National Centre for Miscarriage Research
Birmingham, United Kingdom, B15 2TG
North Bristol NHS Trust
Bristol, United Kingdom
Countess of Chester Hospital HNS Foundation Trust
Chester, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom
Saint Mary's Hospital
Manchester, United Kingdom
Royal Victoria Infirmary
Newcastle Upon Tyne, United Kingdom
Sponsors and Collaborators
University of Birmingham
Investigators
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Study Chair: Laurentiu Craciunas Tommy's National Centre for Miscarriage Research

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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT03442335     History of Changes
Other Study ID Numbers: RG_17-179
233994 ( Other Identifier: IRAS )
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Birmingham:
embryo implantation
endometrial receptivity
chromohysteroscopy
transcriptomics
proteomics
metabolomics
implantation window
luteal phase

Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications