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Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

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Igenomix

Status

Unknown

Conditions

Infertility

Treatments

Other: Day 3 embryo transfer
Other: Day 5 embryo transfer

Study type

Interventional

Funder types

Industry

Identifiers

NCT02189369
1311-FIVI-135-CS

Details and patient eligibility

About

This clinical validation study is being carried out to validate the efficacy of a test measuring the clinical application of prostaglandins present in the endometrial fluid in patients, 24 hours before the embryonic transfer. This test is capable of predicting endometrial receptivity without the need of performing a biopsy.

Enrollment

120 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Any IVF patient being treated for single or double embryo transfer
  • BMI: 20 - 30
  • Normal ovarian response (7 - 8 ovocitos) in IVF treatment with AFC ≥ 8, (AFC = Antral Follicle Count)
  • Elective embryo transfer
  • Normal uterine cavity
  • Age: ≤ 38 years old for patients with own oocytes; ≤ 50 years old for patients with donated oocytes.

Exclusion criteria

  • Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)
  • Patients with severe male factor ( ≥ 2*106 espermatozoides/ml).

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 8 patient groups

Day 3 embryo-Own-above cutoff
Experimental group
Description:
Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
Treatment:
Other: Day 3 embryo transfer
Day 5 embryo-Own-above cutoff
Experimental group
Description:
Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
Treatment:
Other: Day 5 embryo transfer
Day 3 embryo-Donor-above cutoff
Experimental group
Description:
Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
Treatment:
Other: Day 3 embryo transfer
Day 5 embryo-Donor- above cutoff
Experimental group
Description:
Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
Treatment:
Other: Day 5 embryo transfer
Day 3 embryo-Donor-lower cutoff
Experimental group
Description:
Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
Treatment:
Other: Day 3 embryo transfer
Day 5 embryo-Donor-lower cutoff
Experimental group
Description:
Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
Treatment:
Other: Day 5 embryo transfer
Day 3 embryo-own-lower cutoff
Experimental group
Description:
Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates
Treatment:
Other: Day 3 embryo transfer
Day 5 embryo-own-lower cutoff
Experimental group
Description:
Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates
Treatment:
Other: Day 5 embryo transfer

Trial contacts and locations

2

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Central trial contact

Carlos Gómez, MA

Data sourced from clinicaltrials.gov

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