Status:
UNKNOWN
RCT to Assess the Clinical Benefit of the ERA Test in Infertile Women at Their First IVF/ICSI Cycle
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
RenJi Hospital
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Conditions:
Infertility, Female
IVF/ICSI
Eligibility:
FEMALE
Up to 37 years
Phase:
NA
Brief Summary
Endometrial receptivity takes place in a self-limited period of time during the endometrial mid-secretory stage. This period, named as window of implantation (WOI), is modulated by molecular changes a...
Detailed Description
When the transcriptomic signature of human endometrial receptivity was reported, Igenomix developed the ERA, a molecular tool able to diagnose the endometrial receptivity by NGS and a computational pr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients whose written ICF approved by the 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 undergoing their first IVF/ICSI cycle (first oocyte pick up, freezing all) with their own oocytes that will receive single embryo transfer of frozen blastocyst stage embryos (day 5/6) on an HRT cycle.
- At least 2 morphologically good quality embryos already vitrified in blastocyst stage (day 5/6).
- Maternal Age: ≤37 years to rule out embryo factor in aging patients.
- BMI: 18.5 - 30.0 kg / m2 (both inclusive).
- Normal ovarian reserve (defined as: AFC ≥ 8; AMH level ≥1.0 ng/ml and/or FSH \< 8 mU/ml) before the controlled ovarian stimulation (COS) initiation.
- Serum P levels ≤ 1.5 ng/ml, measured within 24 hours before the hCG administration in the COS cycle.
- Negative serological tests for HIV, HBV, HCV, RPR.
- Exclusion criteria:
- Patients with repeated miscarriages (\> 2 previous biochemical pregnancies or \> 2 spontaneous miscarriages).
- Male partner with severe male factor (spermatozoa \< 2 million/ml). Semen donor is allowed.
- Patients who are intrauterine device (IUD) carriers in the last 3 months before sample collection.
- Adenomyosis or any pathological finding affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas \> 4 cm, or hydrosalpinx must be previously operated at least 3 months before the endometrial samples are obtained. (Note: Patients are allowed to participate if the pathology is corrected before performing any study procedure).
- Embryos analysed using preimplantation genetic testing for aneuploidies (PGT-A).
- Any illness or medical condition that is unstable or affect the safety of the patient and compliance of the study.
Exclusion
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
714 Patients enrolled
Trial Details
Trial ID
NCT04687670
Start Date
August 1 2021
End Date
April 1 2023
Last Update
July 8 2021
Active Locations (3)
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1
Northwest Women's and Children's Hospital
Xi'an, Shaanxi, China, 710000
2
Peking University Third Hospital
Beijing, China, 100191
3
Renji Hospital
Shanghai, China