Incidence of Non Receptive Endometrium in Obese Women

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205866
• Other study ID #: 1403-VLC-012-JB
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: July 31, 2017

Study information

• Verified date: June 2019
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 31, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia
United States	Baylor College of Medicine	Houston	Texas
United States	Stamford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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