Incidence of Non Receptive Endometrium in Obese Women

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Endometrial Receptivity Array analysis of endometrial biopsy

• Registration Number: NCT02205866
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Study Start: 2014-08
• Primary Completion: 2017-07
• Study Completion: 2017-07-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 183

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Endometrial Receptivity Array analysis of endometrial biopsy	Non Obese patients
Group B	Endometrial Receptivity Array analysis of endometrial biopsy	Obese patients

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Look for specific endometrial gene patterns.	25 days	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.
Distribution of fat and risk factors	4 months	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.
Evaluate the result of assisted reproduction treatment.	12 months	Relate if the displacement of the WOI induced by the obesity is clinically relevant after the personalized embryo transfer.

Trial Locations

Locations (3)

Stamford University; 🇺🇸 Palo Alto, California, United States

IVI Valencia; 🇪🇸 Valencia, Spain

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States