Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 183
- Locations
- 3
- Primary Endpoint
- Non Receptive Endometrium
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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)
Arms & Interventions
Group B
Obese patients
Intervention: Endometrial Receptivity Array analysis of endometrial biopsy (Other)
Group A
Non Obese patients
Intervention: Endometrial Receptivity Array analysis of endometrial biopsy (Other)
Outcomes
Primary Outcomes
Non Receptive Endometrium
Time Frame: 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 Outcomes
- Look for specific endometrial gene patterns.(25 days)
- Distribution of fat and risk factors(4 months)
- Evaluate the result of assisted reproduction treatment.(12 months)
Investigators
Jose Bellver
Dr. Jose Bellver
Instituto Valenciano de Infertilidad, IVI VALENCIA