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

NCT02280798 | Completed DMC

• 1 other identifier: 1407-MAD-056-MC
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial

Keywords

ERA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hormonal profile

  LH,E2,P4

Study Arms (1)

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

Interventions

Endometrial Biopsy PROCEDURE

4 endometrial biopsy

pilot study

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IVI Madrid: lead
• Igenomix: collaborator

Study Sites (1)

Maria Cerrillo

Madrid, Madrid, 28916, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

endometrial biopsies for ADN analysis

Study Officials

• Cerrillo M Maria, doctor

  IVI Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: November 3, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)