Endometrial Receptivity DiagnosisNCT03091023
Quantitative Identification of Implantation Receptivity by Single Cell Transcriptome Analysis
A study testing Endometrial Biopsy and endometrial fluid collection in people with Endometrial Receptivity Diagnosis, run by Igenomix.
Trial summary
This project aims to study the endometrial transcriptome at the single cell level in both endometrial native tissue (biopsies) and endometrial fluid. Basically, the goals are: 1) To use the resolution provided by single-cell RNA-seq to deconvolute real time dynamics in endometrium transcriptome throughout the… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Receptivity Diagnosis
- What is being tested?
- Endometrial Biopsy and endometrial fluid collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women in natural cycle;
- Normal karyotype;
- Negative serologic tests for HIV, HBV, HCV, RPR;
- BMI: 18 - 30 Kg/m2 (both included);
- Women with regular menstrual cycle (3-4/28-30 days).
Who cannot join
- Patients who had carried an intrauterine device in the previous 3 months;
- Patients who have taken hormonal contraceptives in the previous 2 months;
- Adnexal or uterine pathologies;
- Polycystic ovary;
- Any unstable disease or medical condition that could interfere with the study or put in risk the health of the patient (evaluated by the principal researcher of the research team);
- Any illness or medical unstable condition.
About this study
Official title: Non-invasive Transcriptomic Signature at the Single Cell Level in Endometrial Fluid as a Novel Diagnostic Test of Human Endometrial Receptivity
This project aims to study the endometrial transcriptome at the single cell level in both endometrial native tissue (biopsies) and endometrial fluid. Basically, the goals are: 1) To use the resolution provided by single-cell RNA-seq to deconvolute real time dynamics in endometrium transcriptome throughout the menstrual cycle from artifacts produced by known population heterogeneity, and 2) To use endometrium fluid to replace endometrium biopsies as signal source to develop a new diagnostic platform to determine the endometrium receptive state which is high resolution and minimally invasive. This study will provide an unprecedented high-resolution characterization of the endometrium cellular hierarchy via whole transcriptome analysis throughout the menstrual stages. These results will lead to a robust definition of stage-defining gene expression signatures and resolve the long-standing inconsistencies originating from bulk tissue studies. The dataset will be further explored via informatics tools to provide biological insights into the dynamics of endometrium and initiate new anchor points for functional studies.
Read the detailed description
Successful embryo implantations for in vitro fertilization require both healthy embryos and a receptive endometrium. The window of implantation (WOI), during which endometrium reaches receptive state, varies among individuals. Displacements of WOI have been reported to be a major cause of repeated implantation failures. However, a reliable diagnostic metric to evaluate endometrial receptive status is lacking. The propose of this study is to use single-cell RNA seq and bioinformatics tools to develop a high-resolution platform to characterize endometrium activities and to measure endometrial receptive state in a non-invasive manner.
First objective is to develop an experimental pipeline to generate high quality single-cell RNA-seq data from endometrial biopsies and endometrial fluid from healthy patients throughout the menstrual cycle at each of these stages: early proliferative (EP; days 0-8), late proliferative (LP; days 9-14), early secretory (ES; days 15-18), mid-secretory or receptive (MS; days 19-23), and late secretory (LS; days 24-30). These tissues will be dissociated mechanically and enzymatically and subjected to microfluidic sorting, single cell transcriptome amplification and analysis. These data will provide the first transcriptome-wide single cell data various cell types of the human endometrium.
Secondly, this study look at establish algorithmic models to distinguish epithelial and stroma populations informatically, without the need to first purify populations of interest. This will enable transcriptome analysis from mixed populations of cells.
Finally evaluate the use of endometrial fluid as an alternative source for receptivity diagnosis analyzing the transcriptome profile of single cells from Endometrial fluid collected from human patients at different menstrual stages. These signatures will also be compared and correlated with signatures obtained from biopsies, which will help us better understand the biological events that lead to the occurrence of these cells in the endometrial fluid and evaluate the potential of extending their use for diagnosis of other endometrium conditions.
- Conditions
- Endometrial Receptivity Diagnosis
- Being tested
- Endometrial Biopsy and endometrial fluid collection
- Keywords
- Endometrial receptivity, Transcriptomic, Single cell, Endometrial fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial Biopsy and endometrial fluid collectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Natural cycle | Active comparator | Endometrial biopsies and endometrial fluid obtained from healthy females throughout the menstrual cycle at each of these stages:
Early proliferative (EP; days 0-8), late proliferative (LP; days 9-14), early secretory (ES; days 15-18), mid-secretory or receptive (MS; days 19-23), and late secretory (LS; days 24-30) Receives: Procedure: Endometrial Biopsy and endometrial fluid collection |
| ERA in HRT cycle | Active comparator | Endometrial biopsy and endometrial fluid obtained from woman undergoing to Endometrial Receptivity Analysis (ERA) in a hormonal replacement therapy (HRT) cycle. Receives: Procedure: Endometrial Biopsy and endometrial fluid collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptomic profile analysis of the endometrial samples by RNA sequencing.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startMar 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Receptivity DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Carlos Simon, Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091023
- Sponsor's protocol ID
- 1603-IGX-016-CS
- Status last verified
- Mar 2017
- First submitted
- 30 Aug 2016
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Transcriptomic Signature at the Single Cell Level in Endometrial Fluid as a Novel Diagnostic Test of Human Endometrial Receptivity
- ClinicalTrials.gov ID
- NCT03091023
- Acronym / sponsor ID
- 1603-IGX-016-CS
- Conditions
- Endometrial Receptivity Diagnosis
- Keywords
- Endometrial receptivity, Transcriptomic, Single cell, Endometrial fluid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to study the endometrial transcriptome at the single cell level in both endometrial native tissue (biopsies) and endometrial fluid. Basically, the goals are: 1) To use the resolution provided by single-cell RNA-seq to deconvolute real time dynamics in endometrium transcriptome throughout the menstrual cycle from artifacts produced by known population heterogeneity, and 2) To use endometrium fluid to replace endometrium biopsies as signal source to develop a new diagnostic platform to determine the endometrium receptive state which is high resolution and minimally invasive. This study will provide an unprecedented high-resolution characterization of the endometrium cellular hierarchy via whole transcriptome analysis throughout the menstrual stages. These results will lead to a robust definition of stage-defining gene expression signatures and resolve the long-standing inconsistencies originating from bulk tissue studies. The dataset will be further explored via informatics tools to provide biological insights into the dynamics of endometrium and initiate new anchor points for functional studies.
Detailed description
Successful embryo implantations for in vitro fertilization require both healthy embryos and a receptive endometrium. The window of implantation (WOI), during which endometrium reaches receptive state, varies among individuals. Displacements of WOI have been reported to be a major cause of repeated implantation failures. However, a reliable diagnostic metric to evaluate endometrial receptive status is lacking. The propose of this study is to use single-cell RNA seq and bioinformatics tools to develop a high-resolution platform to characterize endometrium activities and to measure endometrial receptive state in a non-invasive manner.
First objective is to develop an experimental pipeline to generate high quality single-cell RNA-seq data from endometrial biopsies and endometrial fluid from healthy patients throughout the menstrual cycle at each of these stages: early proliferative (EP; days 0-8), late proliferative (LP; days 9-14), early secretory (ES; days 15-18), mid-secretory or receptive (MS; days 19-23), and late secretory (LS; days 24-30). These tissues will be dissociated mechanically and enzymatically and subjected to microfluidic sorting, single cell transcriptome amplification and analysis. These data will provide the first transcriptome-wide single cell data various cell types of the human endometrium.
Secondly, this study look at establish algorithmic models to distinguish epithelial and stroma populations informatically, without the need to first purify populations of interest. This will enable transcriptome analysis from mixed populations of cells.
Finally evaluate the use of endometrial fluid as an alternative source for receptivity diagnosis analyzing the transcriptome profile of single cells from Endometrial fluid collected from human patients at different menstrual stages. These signatures will also be compared and correlated with signatures obtained from biopsies, which will help us better understand the biological events that lead to the occurrence of these cells in the endometrial fluid and evaluate the potential of extending their use for diagnosis of other endometrium conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural cycle | Active comparator | Procedure: Endometrial Biopsy and endometrial fluid collectionEndometrial biopsies and endometrial fluid obtained from healthy females throughout the menstrual cycle at each of these stages: Early proliferative (EP; days 0-8), late proliferative (LP; days 9-14), early secretory (ES; days 15-18), mid-secretory or receptive (MS; days 19-23), and late secretory (LS; days 24-30) |
| ERA in HRT cycle | Active comparator | Procedure: Endometrial Biopsy and endometrial fluid collectionEndometrial biopsy and endometrial fluid obtained from woman undergoing to Endometrial Receptivity Analysis (ERA) in a hormonal replacement therapy (HRT) cycle. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy women in natural cycle;
- Normal karyotype;
- Negative serologic tests for HIV, HBV, HCV, RPR;
- BMI: 18 - 30 Kg/m2 (both included);
- Women with regular menstrual cycle (3-4/28-30 days).
Key exclusion criteria (6 listed)
- Patients who had carried an intrauterine device in the previous 3 months;
- Patients who have taken hormonal contraceptives in the previous 2 months;
- Adnexal or uterine pathologies;
- Polycystic ovary;
- Any unstable disease or medical condition that could interfere with the study or put in risk the health of the patient (evaluated by the principal researcher of the research team);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial Biopsy and endometrial fluid collection | Procedure or surgery | ERA in HRT cycle, Natural cycle |
Primary outcome
Transcriptomic profile analysis of the endometrial samples by RNA sequencing.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial Biopsy and endometrial fluid collection in people with Endometrial Receptivity Diagnosis, run by Igenomix.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptomic profile analysis of the endometrial samples by RNA sequencing. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.