Clinical Study of PGT-A Versus PGT-A+ERA

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2022
• Main ID: NCT03530254
• Date of registration: 08/05/2018
• Prospective Registration: Yes
• Primary sponsor: Igenomix
• Public title: Clinical Study of PGT-A Versus PGT-A+ERA PGT-A&ERA
• Scientific title: International Multi-center, Randomized and Controlled Clinical Study, to Evaluate the Clinical Benefit of the ERA Test in Infertile Patients Undergoing Assisted Reproduction Treatment and Medical Indication of PGT-A.
• Date of first enrolment: May 28, 2018
• Target sample size: 368
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03530254
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Argentina, Brazil, Canada, Chile, Georgia, India, Italy, Mexico, Spain, Taiwan, Turkey, United States, Vietnam

Contacts

• Name: Carlos Simón, MD PhD
• Affiliation: Igenomix

Key inclusion & exclusion criteria

Inclusion Criteria:

- Majority of age patients whose written informed consent approved by the Ethics
Committee (EC) has been obtained, after having been duly informed of the nature of the
study and voluntarily accepted to participate after being fully aware of the potential
risks, benefits and any discomfort involved.

- Patients who already have frozen euploid blastocysts (day 5/6 development) analysed by
PGT-A.

- Patients with embryos obtained from their own oocytes fertilized by Intracytoplasmic
Sperm Injection (ICSI) or In vitro fertilization (IVF).

- Patients with an expected embryo transfer of one or two embryos (Single ET or Double
ET) in a HRT cycle.

- Body Mass Index: 18,5-30 Kg/m2.

Exclusion Criteria:

- Presence of pathologies or malformations that affect the uterine cavity such as
polyps, intramural myomas = 4cm or submucosal, septum or hydrosalpinx during the
patient's participation in the study. Patients suffering these pathologies before or
after their inclusion in the study are allowed to participate if the pathology is
corrected before performing any study procedure.

- Any illness or medical condition that is unstable or which, according to medical
criteria, may put at risk the patient's safety and her compliance in the study.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility of Uterine Origin

Intervention(s)

Diagnostic Test: ERA Test

Diagnostic Test: PGT-A

Primary Outcome(s)

Live birth rate [Time Frame: 40 weeks]

Secondary Outcome(s)

Clinical miscarriages [Time Frame: 20 weeks]

Clinical pregnancy [Time Frame: 20 weeks]

Ectopic pregnancies [Time Frame: 20 weeks]

Obstetric complications [Time Frame: 40 weeks]

Biochemical pregnancy [Time Frame: 20 weeks]

Implantation rate [Time Frame: 12 weeks]

Secondary ID(s)

IGX1-P&E-DV-17-08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors