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

Endometrial Clinical Trial

— ERA  

Official title:

Endometrial Gene Expression in Different Protocols of Endometrial Preparation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280798
• Other study ID #: 1407-MAD-056-MC
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: February 22, 2016
• Start date: December 2014
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial

Intervention

Procedure:
• Endometrial Biopsy
4 endometrial biopsy

Locations

Country	Name	City	State
Spain	Maria Cerrillo	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
IVI Madrid	Igenomix

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hormonal profile	Hormonal profile different dates of protocols	LH,E2,P4