Incidence of Non Receptive Endometrium in Obese Women

N/ACompletedNCT02205866

Instituto Valenciano de Infertilidad, IVI VALENCIA183 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

183

Conditions

Infertility

Interventions

Endometrial Receptivity Array analysis of endometrial biopsyOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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)

Locations (3)

Stamford University

Palo Alto, California, United States

Baylor College of Medicine

Houston, Texas, United States

IVI Valencia

Valencia, Spain

Outcomes

Primary Outcomes

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.

Time frame: 25 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.