Incidence of Non Receptive Endometrium in Obese Women

Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.

This study evaluates the incidence of Non Receptive endometrium in obese infertile women compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's Window of Implantation, regardless of the histological appearance of the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Endometrial Receptivity Array analysis of endometrial biopsy

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • IVI Valencia
• United States
  • California
    • Palo Alto, California, United States, 94305-5101
      • Stamford University
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Infertile women: > 1 year of regular unprotected intercourse without evidence of pregnancy.
• Normal uterus by 2D/3D ultrasound scan and/or hysteroscopy
• No endometriosis
• Presence of both ovaries
• < 45 years old (in ovum donation, outcome parameters are not affected until this age in all the current published studies).

Exclusion Criteria:

• Hydrosalpinx
• Stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy.
• Implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy)
• Recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Non Obese patients	Other: Endometrial Receptivity Array analysis of endometrial biopsy; A biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome.
Experimental: Group B; Obese patients	Other: Endometrial Receptivity Array analysis of endometrial biopsy; A biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non Receptive Endometrium	To evaluate the incidence of Not Receptive endometrium in obese infertile women compared to infertile normal weight women using an adequate sample size.	25 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of fat and risk factors	Carry out a subanalysis concerning the distribution of central and peripheric fat and risk factors of metabolic syndrome including: Age (years); Height (m); Weight (kg) ; BMI (kg/m2); Waist (cm) ; Hip (cm); Index waist-hip ratio (WHR) waist (cm) / hip (cm); Blood pressure; insulinemia Fasting blood glucose (mmol / L); PTG ( tolerance oral glucose ) (mmol / L), Total cholesterol and fractions; Triglycerides Microalbuminuria; bA1C, HC-reactive protein.	4 months
Look for specific endometrial gene patterns.	Find patterns of expression of specific genes in endometrial obese women: we will by analyzing the expression of 238 genes obtained after endometrial endometrial biopsy.	25 days
Evaluate the result of assisted reproduction treatment.	Relate if the displacement of the WOI induced by the obesity is clinically relevant after the personalized embryo transfer.	12 months

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Investigators: Principal Investigator: Jose Bellver, MD PhD, IVI Valencia

Publications and helpful links

General Publications

• Comstock IA, Diaz-Gimeno P, Cabanillas S, Bellver J, Sebastian-Leon P, Shah M, Schutt A, Valdes CT, Ruiz-Alonso M, Valbuena D, Simon C, Lathi RB. Does an increased body mass index affect endometrial gene expression patterns in infertile patients? A functional genomics analysis. Fertil Steril. 2017 Mar;107(3):740-748.e2. doi: 10.1016/j.fertnstert.2016.11.009. Epub 2016 Dec 2.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: July 25, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 1403-VLC-012-JB