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Incidence of Non Receptive Endometrium in Obese Women

I

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status

Completed

Conditions

Infertility

Treatments

Other: Endometrial Receptivity Array analysis of endometrial biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02205866
1403-VLC-012-JB

Details and patient eligibility

About

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.

Enrollment

183 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

183 participants in 2 patient groups

Group A
Active Comparator group
Description:
Non Obese patients
Treatment:
Other: Endometrial Receptivity Array analysis of endometrial biopsy
Group B
Experimental group
Description:
Obese patients
Treatment:
Other: Endometrial Receptivity Array analysis of endometrial biopsy

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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