Infertility
Conditions
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.
Interventions
OTHEREndometrial 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.
Sponsors
Instituto Valenciano de Infertilidad, IVI VALENCIA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Spain, United States
Outcome results
None listed