Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01954758 |
Date of registration:
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26/09/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer
ERA RCT |
Scientific title:
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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:
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November 25, 2013 |
Target sample size:
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569 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01954758 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Brazil
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Bulgaria
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Japan
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Mexico
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Panama
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Serbia
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Singapore
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Spain
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Turkey
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United States
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Contacts
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Name:
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Carlos Simon, MDPhD |
Address:
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Telephone:
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Email:
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Affiliation:
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IVI Valencia / Igenomix |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Endometrial Receptivity
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Intervention(s)
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Other: Frozen Embryo Transfer (FET)
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Other: Fresh Embryo Transfer (ET)
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Other: personalized Embryo Transfer (pET)
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Primary Outcome(s)
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Live birth delivery rate
[Time Frame: 40 weeks]
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Secondary Outcome(s)
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Biochemical pregnancies
[Time Frame: 20 weeks]
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Implantation rate
[Time Frame: 12 weeks]
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Clinical miscarriages
[Time Frame: 20 weeks]
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Cumulative live birth delivery rate
[Time Frame: 12 months]
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Ectopic pregnancies
[Time Frame: 20 weeks]
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Cumulative pregnancy rate
[Time Frame: 12 months]
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Cumulative implantation rate
[Time Frame: 12 months]
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Pregnancy rate
[Time Frame: 20 weeks]
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Secondary ID(s)
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1304-C-107-CS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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