Infertility, FemaleNCT04052464
The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
An observational study of Infertility, Female and IVF, run by Prelife Kft.
Trial summary
The objective of the study is to gain a better understanding of the gene expression changes in the endometrial biopsy especially whether the endometrium has reached a receptive status, i.e. the implantation window, or not. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Infertility, Female, IVF
- What is being tested?
- endometrium biopsy, endometrium lavage and repeated endometrium lavage
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2016to 28 Aug 2018
- Phase
- Observational
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women participating in the diagnostic evaluation of infertility. The patients are contacted for participation in the study during the diagnostic evaluation of their infertility at specialized infertility or gynaecological clinic.
Who may be able to join
- infertile women participating in the diagnostic evaluation of infertility.
Who cannot join
- patients who are legally incapable or partially capable
- pregnancy should be excluded before sampling
- bleeding problems
- the active phase of severe psychiatric disorders
About this study
The objective of the study is to gain a better understanding of the gene expression changes in the endometrial biopsy especially whether the endometrium has reached a receptive status, i.e. the implantation window, or not.
Read the detailed description
The endometrium goes through huge gene expression changes during a cycle, the cells are transformed, the mucous membrane thickens, then loosens, and finally sheds. In this process, the expression of the genes also goes through significant changes, which can be determined from a small tissue sample.
Endometrium biopsy samples can be used for endometrium phasing. A question of the study is the feasibility of using for endometrium phasing beside endometrium tissue biopsy also samples generated by endometrium lavage. The advantage of this latter method is that it is minimally invasive, it does not cause haemorrhage and has minimal side effects. In some selected cases endometrial lavage will be performed on the same day with endometrial tissue sampling together with the drawing of a peripheral blood sample.
A list of potential biomarkers was proposed from the meta-analysis of published gene expression datasets. From the endometrium derived samples, RNA will be isolated and gene expression biomarkers will be measured. Expression profiles will be compared to published reference samples.
- Conditions
- Infertility, Female, IVF
- Being tested
- endometrium biopsy, endometrium lavage, repeated endometrium lavage
- Keywords
- gene expression, biomarkers, implantation window, embryo transfer, endometrium, biopsy, lavage, liquid biopsy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrium biopsyOther
All patients will have endometrium biopsy.
endometrium lavageOther
In some selected cases biopsy is preceded by endometrium lavage.
repeated endometrium lavageOther
Endometrium lavage is repeated during the same cycle.
| Study group | Role | What they receive |
|---|---|---|
| endometrium biopsy only | In these cases, only endometrium biopsy is investigated for the selected biomarkers gene expression profile. Receives: Other: endometrium biopsy | |
| endometrium lavage followed by endometrium tissue biopsy | In these cases before the endometrium tissue biopsy, an endometrial lavage is performed and from both samples, the selected biomarkers gene expression profile are investigated. Receives: Other: endometrium biopsy; Other: endometrium lavage | |
| serial endometrium lavage followed by endometrium biopsy | In these cases before the endometrium tissue biopsy, at different days endometrial lavage samples are taken. From all samples, the selected biomarkers gene expression profile are investigated. Receives: Other: endometrium biopsy; Other: repeated endometrium lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression profile
the endometrium derived samples are measured for the mRNA level expression of a selected list of biomarkers as it follows: ABCC3, ACTB, ADAMTS2, ADAMTS8, ARG2, ASPN, B2M, BAMBI, C10orf10, C1QTNF6, C2CD4A, CCDC71L, CD55, CEBPD, CP, CRISP3, CTHRC1, CYP24A1, CSRP2, DDX52, DPP4, DUOX1, DUOXA1, EDNRB, FCER1G, G0S2, GADD45G, GNG2, GNG4, GPX3, GRAMD1C, GREM2, GZMA, HPGD, HTR2B, IGFBP1, IGFBP3, IGFBP6, IL1B, IRX3, ITGA2, ITGB6, KAL1, KCND2, KCNK3, LCP2, LEFTY2, LRP4, LTBP2, LUM, MAOA, MAP2K6, MFSD4, MMP10, MS4A7, MT1M, MUC16, NID2, NNMT, OPRK1, PAEP, PDE4B, PHLDB2, PKHD1L1, PLAT, PLD1, POLR2A, PPIA, RARRES1, RDH10, RGS1, RHOB, RHPN2, RIMKLB, SGIP1, SLAIN1, SLC15A1, SLC15A2, SLC1A1, SLC26A7, SLC5A3, SOD2, SPP1, SYT11, TBP, TCN1, TFPI2, THBS1, TIMP3, TMC5, TMED6, TNFRSF11B, TSPAN8
Measured: measurements are performed within 3 weeks after samples are shipped to the laboratory
endometrium phase assesment
based on the gene expression profile endometrium samples are phase assigned based on published reference samples
Measured: phase assignment is performed within two weeks after the measurements are performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start26 Sep 2016
- Primary completion20 Dec 2017
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prelife Kft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Balint Laszlo Balint, Prelife Kft
- Investigators
- Balint L. Balint, MD, PhD, Principal investigator, Prelife Kft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052464
- Sponsor's protocol ID
- PRELIFE-V8
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared as the approval does not allow sharing of the individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
- ClinicalTrials.gov ID
- NCT04052464
- Acronym / sponsor ID
- PRELIFE-V8
- Conditions
- Infertility, Female, IVF
- Keywords
- gene expression, biomarkers, implantation window, embryo transfer, endometrium, biopsy, lavage, liquid biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Prelife KftIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 9 Aug 2019 (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.
The objective of the study is to gain a better understanding of the gene expression changes in the endometrial biopsy especially whether the endometrium has reached a receptive status, i.e. the implantation window, or not.
Detailed description
The endometrium goes through huge gene expression changes during a cycle, the cells are transformed, the mucous membrane thickens, then loosens, and finally sheds. In this process, the expression of the genes also goes through significant changes, which can be determined from a small tissue sample.
Endometrium biopsy samples can be used for endometrium phasing. A question of the study is the feasibility of using for endometrium phasing beside endometrium tissue biopsy also samples generated by endometrium lavage. The advantage of this latter method is that it is minimally invasive, it does not cause haemorrhage and has minimal side effects. In some selected cases endometrial lavage will be performed on the same day with endometrial tissue sampling together with the drawing of a peripheral blood sample.
A list of potential biomarkers was proposed from the meta-analysis of published gene expression datasets. From the endometrium derived samples, RNA will be isolated and gene expression biomarkers will be measured. Expression profiles will be compared to published reference samples.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| endometrium biopsy only | – | Other: endometrium biopsyIn these cases, only endometrium biopsy is investigated for the selected biomarkers gene expression profile. |
| endometrium lavage followed by endometrium tissue biopsy | – | Other: endometrium biopsy, Other: endometrium lavageIn these cases before the endometrium tissue biopsy, an endometrial lavage is performed and from both samples, the selected biomarkers gene expression profile are investigated. |
| serial endometrium lavage followed by endometrium biopsy | – | Other: endometrium biopsy, Other: repeated endometrium lavageIn these cases before the endometrium tissue biopsy, at different days endometrial lavage samples are taken. From all samples, the selected biomarkers gene expression profile are investigated. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women participating in the diagnostic evaluation of infertility. The patients are contacted for participation in the study during the diagnostic evaluation of their infertility at specialized infertility or gynaecological clinic.
Key inclusion criteria (1 listed)
- infertile women participating in the diagnostic evaluation of infertility.
Key exclusion criteria (4 listed)
- patients who are legally incapable or partially capable
- pregnancy should be excluded before sampling
- bleeding problems
- the active phase of severe psychiatric disorders
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 |
|---|---|---|
| endometrium biopsyAll patients will have endometrium biopsy. | Other | endometrium biopsy only, endometrium lavage followed by endometrium tissue biopsy, serial endometrium lavage followed by endometrium biopsy |
| endometrium lavageIn some selected cases biopsy is preceded by endometrium lavage. | Other | endometrium lavage followed by endometrium tissue biopsy |
| repeated endometrium lavageEndometrium lavage is repeated during the same cycle. | Other | serial endometrium lavage followed by endometrium biopsy |
Primary outcome
gene expression profile
Time frame: measurements are performed within 3 weeks after samples are shipped to the laboratory
the endometrium derived samples are measured for the mRNA level expression of a selected list of biomarkers as it follows: ABCC3, ACTB, ADAMTS2, ADAMTS8, ARG2, ASPN, B2M, BAMBI, C10orf10, C1QTNF6, C2CD4A, CCDC71L, CD55, CEBPD, CP, CRISP3, CTHRC1, CYP24A1, CSRP2, DDX52, DPP4, DUOX1, DUOXA1, EDNRB, FCER1G, G0S2, GADD45G, GNG2, GNG4, GPX3, GRAMD1C, GREM2, GZMA, HPGD, HTR2B, IGFBP1, IGFBP3, IGFBP6, IL1B, IRX3, ITGA2, ITGB6, KAL1, KCND2, KCNK3, LCP2, LEFTY2, LRP4, LTBP2, LUM, MAOA, MAP2K6, MFSD4, MMP10, MS4A7, MT1M, MUC16, NID2, NNMT, OPRK1, PAEP, PDE4B, PHLDB2, PKHD1L1, PLAT, PLD1, POLR2A, PPIA, RARRES1, RDH10, RGS1, RHOB, RHPN2, RIMKLB, SGIP1, SLAIN1, SLC15A1, SLC15A2, SLC1A1, SLC26A7, SLC5A3, SOD2, SPP1, SYT11, TBP, TCN1, TFPI2, THBS1, TIMP3, TMC5, TMED6, TNFRSF11B, TSPAN8
endometrium phase assesment
Time frame: phase assignment is performed within two weeks after the measurements are performed.
based on the gene expression profile endometrium samples are phase assigned based on published reference samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be shared as the approval does not allow sharing of the individual participant data.
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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.
Balint L. Balint, MD, PhD principal investigator
Prelife Kft
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and IVF, run by Prelife Kft.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 9 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
gene expression profile (time frame: measurements are performed within 3 weeks after samples are shipped to the laboratory). The study lists 2 primary outcomes in all. 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 9 Aug 2019.