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OpenTrials
Completed

NCT Number: NCT02280798

Endometrial Gene Expression in Different Protocols of Endometrial Preparation for Embryo Transfer'

Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.

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Key information

Conditions

Age range

18 year–34 year

Sex eligibility

Female

Study type

Observational

Primary location

Maria Cerrillo

Madrid, 28916, Spain

About this study

Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The clinical results in different publications showed different results, some of them described the natural cycle superior as the substituted cycles, and in contrast other large series showed superior results in substituted cycles than natural but with an increased of pregnancies losses. The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18 and 35 years
  • regular menstrual cycles (between 25 and 35 days)
  • normal basal hormones(follicle-stimulating hormone [FSH] and LH <10 IU/ mL and estradiol <60 pg/mL)
  • normal karyotype
  • body massindex between 18 and 25 kg/m2
  • negative serology
  • normal cervical cytology in the past year, and a vaginal ultrasound without evidence of any pathologic conditions

Exclusion criteria

  • endometriosis
  • polycystic ovariansyndrome
  • use of an intrauterine device in the last 3 months.

Treatment and study plan

endometrial biopsy

Procedure

4 endometrial biopsy

Primary outcomes

  1. Endometrial receptivity

    Time frame: 4 months

    Total RNA was extracted using the TRIzol method according to the manufacturer's recommendations (Life Technologies). Approximately 1-2 mg of total RNA was obtained per milligram of endometrial tissue. The RNA quality was assessed by loading 300 ng of total RNA onto an RNA LabChip and was analyzed in an A2100 Bioanalyzer (Agilent Technologies). Only samples with a RNA integrity number >7 were selected for microarray analysis.

    Sample preparation and hybridization was adapted from the Agilent technical manual. Hybridized microarrays were scanned in an Axon 4100A scanner (Molecular Devices), and the data were extracted with the GenePix Pro 6.0 software (Molecular Devices). The ERA microarray validation has been previously published. Reverse transcriptase-polymerase chain reaction (PCR) was performed for four selected up-regulated genes: GPX3, FXYD2, SPP1, and MT1G.

    The ERA gene expression values were preprocessed, normalized, and statistically analyzed. Briefly, the half background

Secondary outcomes

  1. Hormonal profile

    Time frame: LH,E2,P4

    Hormonal profile different dates of protocols

Sponsors and collaborators

Lead sponsor

IVI Madrid

Other

Collaborators

  • Igenomix

Registry information

Official study title

Endometrial Gene Expression in Different Protocols of Endometrial Preparation

Acronym: ERA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2014
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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