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The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods

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ClinicalTrials.gov Identifier: NCT04052464
Recruitment Status : Completed
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Balint Laszlo Balint, Prelife Kft

Brief 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.

Condition or disease Intervention/treatment
Infertility, Female IVF Other: endometrium biopsy Other: endometrium lavage Other: repeated endometrium lavage

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.


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Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Actual Study Start Date : September 26, 2016
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : August 28, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
endometrium biopsy only
In these cases, only endometrium biopsy is investigated for the selected biomarkers gene expression profile.
Other: endometrium biopsy
All patients will have 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.
Other: endometrium biopsy
All patients will have endometrium biopsy.

Other: endometrium lavage
In some selected cases biopsy is preceded by 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.
Other: endometrium biopsy
All patients will have endometrium biopsy.

Other: repeated endometrium lavage
Endometrium lavage is repeated during the same cycle.




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study aims to better understand the component of female infertility, therefore, is investigating only women.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • infertile women participating in the diagnostic evaluation of infertility.

Exclusion Criteria:

  • patients who are legally incapable or partially capable
  • pregnancy should be excluded before sampling
  • bleeding problems
  • the active phase of severe psychiatric disorders

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): NCT04052464


Sponsors and Collaborators
Prelife Kft
Investigators
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Principal Investigator: Balint L. Balint, MD, PhD Prelife Kft

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Responsible Party: Balint Laszlo Balint, Principal Investigator, Prelife Kft
ClinicalTrials.gov Identifier: NCT04052464     History of Changes
Other Study ID Numbers: PRELIFE-V8
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared as the approval does not allow sharing of the individual participant data.

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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 Balint Laszlo Balint, Prelife Kft:
gene expression
biomarkers
implantation window
embryo transfer
endometrium
biopsy
lavage
liquid biopsy
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female