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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

Tracking Information
First Submitted Date August 6, 2019
First Posted Date August 9, 2019
Last Update Posted Date August 9, 2019
Actual Study Start Date September 26, 2016
Actual Primary Completion Date December 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Official Title The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Infertility, Female
  • IVF
Intervention
  • Other: endometrium biopsy
    All patients will have endometrium biopsy.
  • Other: endometrium lavage
    In some selected cases biopsy is preceded by endometrium lavage.
  • Other: repeated endometrium lavage
    Endometrium lavage is repeated during the same cycle.
Study Groups/Cohorts
  • endometrium biopsy only
    In these cases, only endometrium biopsy is investigated for the selected biomarkers gene expression profile.
    Intervention: 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.
    Interventions:
    • 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.
    Interventions:
    • Other: endometrium biopsy
    • Other: repeated endometrium lavage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 8, 2019)
67
Original Actual Enrollment Same as current
Actual Study Completion Date August 28, 2018
Actual Primary Completion Date December 20, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
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.
Ages 25 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04052464
Other Study ID Numbers PRELIFE-V8
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Balint Laszlo Balint, Prelife Kft
Study Sponsor Prelife Kft
Collaborators Not Provided
Investigators
Principal Investigator: Balint L. Balint, MD, PhD Prelife Kft
PRS Account Prelife Kft
Verification Date August 2019