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

Endometrial Gene Expression in Different Protocols of Endometrial Preparation

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.

Study Overview

• Status: Completed
• Conditions: Endometrial
• Intervention / Treatment: Procedure: Endometrial Biopsy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28916
    • Maria Cerrillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

A total of 5 volunteers from our egg donation program were included in the study from Setember 2014 to jnuary 2015

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

pilot study; A total of 5 volunteers from our egg donation program were included in the study with 4 endometrial biopsies for each one after 4 diferente protocols; Endometrial biopsy after Stimulated cycle; Endometrial biopsy after Natural Cycle; Endometrial biopsy after Natural modified cycle: the biopsy is taken seven days after the hCG; Endometrial biopsy after Hormone Replacement Therapy Cycle

Procedure: Endometrial Biopsy; 4 endometrial biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial receptivity	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	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hormonal profile	Hormonal profile different dates of protocols	LH,E2,P4

Collaborators and Investigators

• Sponsor: IVI Madrid
• Collaborators: Igenomix
• Investigators: Principal Investigator: Cerrillo M Maria, doctor, IVI Madrid

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: ERA
• Other Study ID Numbers: 1407-MAD-056-MC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES