Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT06629766
Eligibility Criteria:
Inclusion Criteria:
* Undergoing first IVF cycle
* Electing single embryo transfer
* Electing PGT-A of their embryos
* Female partners age \<42 years old at start of VOR cycle, but \>18 years old.
* AMH ≥ 1.2 ng/mL
* AFC ≥ 8
* FSH ≤ 12IU/L
* At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize
* Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure
Exclusion Criteria:
* Contraindication to IVF
* Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)
* Male partner with azoospermia or oligozoospermia (\<500,000 total motile spermatozoa on the most recent semen analysis within one year of enrollment)
* Planned for previously cryopreserved sperm to be used for ICSI
* Donor sperm
* Male partner with Y-chromosome microdeletion
* Male partner with any Karyotype other than 46,XY
* Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures
* Uncorrected hydrosalpinges that communicate with the endometrial cavity
* Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid
* Donor oocyte or embryo cycles
* Gestational carriers
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
41 Years
Study:
NCT06629766
Study Brief:
Protocol Section:
NCT06629766