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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01954758
Date of registration: 26/09/2013
Prospective Registration: Yes
Primary sponsor: Igenomix
Public title: The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer ERA RCT
Scientific title: Clinical Study, International, Multicentre, Prospective, Randomised, Interventional and Controlled, Comparing Fresh Embryo Transfer (ET) Versus Frozen Embryo Transfer (FET) and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Analysis) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection)
Date of first enrolment: November 25, 2013
Target sample size: 569
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01954758
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Belgium Brazil Bulgaria Japan Mexico Panama Serbia Singapore
Spain Turkey United States
Contacts
Name:     Carlos Simon, MDPhD
Address: 
Telephone:
Email:
Affiliation:  IVI Valencia / Igenomix
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients indicated to undergo a cycle of IVF/ICSI with their own oocytes.

2. Age = 37 years

3. BMI: 18.5 to 30

4. Normal ovarian reserve (AFC = 8; FSH < 8)

5. The most appropriated stimulation protocol will be decided by their doctor.

6. Blastocyst transfer (on day 5 or 6)

7. Blastocyst vitrification with open protocols (Cryotop, Cryoleaf, or Cryolock) or
closed protocols (Cryotip or CBSStraw.)

8. Any pathology affecting the endometrial cavity such as polyps/sub-mucosal myomas,
intramural myomas > 4 cm, or hydrosalpinx affecting the endometrial cavity must be
previously operated.

Exclusion Criteria:

1. Patients with recurrent miscarriages (> 2 previous biochemical pregnancies or > 2
spontaneous miscarriages)

2. Patients with a severe male factor (spermatozoa < 2 million/ml)

3. Patients with implantation failure (>3 failed cycles with good quality embryos)

Post-Randomization Exclusion Criteria:

1. Endogenous progesterone level = 1,5 ng/ml at the day of hCG administration in all
groups.

2. Absence of blastocysts (day 5 or 6) for embryo transfer.

3. Risk of ovarian hyperstimulation syndrome in any of the three groups and therefore a
clinical indication to cancel the transfer cycle where the stimulated patient is from
group A (ET).

Note: PGT-A is not an inclusion criteria neither an exclusion criteria, therefore those
cycles in which PGT-A was performed will be included



Age minimum: 18 Years
Age maximum: 37 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Endometrial Receptivity
Intervention(s)
Other: Frozen Embryo Transfer (FET)
Other: Fresh Embryo Transfer (ET)
Other: personalized Embryo Transfer (pET)
Primary Outcome(s)
Live birth delivery rate [Time Frame: 40 weeks]
Secondary Outcome(s)
Biochemical pregnancies [Time Frame: 20 weeks]
Implantation rate [Time Frame: 12 weeks]
Clinical miscarriages [Time Frame: 20 weeks]
Cumulative live birth delivery rate [Time Frame: 12 months]
Ectopic pregnancies [Time Frame: 20 weeks]
Cumulative pregnancy rate [Time Frame: 12 months]
Cumulative implantation rate [Time Frame: 12 months]
Pregnancy rate [Time Frame: 20 weeks]
Secondary ID(s)
1304-C-107-CS
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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