Incidence of Non Receptive Endometrium in Obese Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Other: Endometrial Receptivity Array analysis of endometrial biopsy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Non Obese patients | Other: Endometrial Receptivity Array analysis of endometrial biopsy<br>* 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.<br>|
| Experimental: Group B<br>Obese patients | Other: Endometrial Receptivity Array analysis of endometrial biopsy<br>* 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.<br>|

What is the study measuring?
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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 |