Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: PGT for Aneuploidy Does Not Enhance Live Birth in Young Patients (≤35 Years): a Randomized Controlled Trial of Single Blastocyst Frozen Embryo Transfers (ClinicalTrials.Gov ID: NCT03095053)
Brief Summary: Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF cycles. Since the inception of IVF, non-invasive morphology based scoring has been the most widely used embryo selection method, resulting in relatively low embryo implantation rates. Our understanding of the optimal conditions required for in vitro embryo culture in IVF has advanced significantly over the past two decades. The implementation of improved in vitro embryo culture technologies (i.e., culture media and incubators) has resulted in an increase in the number of good quality embryos and consequently in increased numbers of blastocysts. While blastocyst transfers have seemingly improved the reproductive outcomes of IVF, they still remain suboptimal. The main objective of this randomized controlled trial (RCT) will be to investigate whether preimplantation genetic testing (i.e., PGT with comprehensive chromosome screening (CCS)) for aneuploidy is a superior embryo selection method, with the live birth outcomes of euploid blastocyst frozen embryo transfers (FET) compared with the LB outcomes of unknown-ploidy blastocyst FET, with blastocysts selected on (standard) morphological score.

Methods This RCT will be conducted at a single private IVF centre performing routine segmented-IVF, with intracytoplasmic sperm injection (ICSI), blastocyst freeze-all, and artificial frozen embryo transfer (art-FET). Normo-ovulatory infertile patients, with maternal age ≤35 years and at least two blastocysts with a morphology score of 2BB cryopreserved, will be randomized by computer-generated randomized allocation to either the PGT or morphology arm of the trial. All transfers will be single embryo transfers (SET), with only the first FET cycles following freeze-all to be analyzed.

Consent and Ethics Akdeniz University Medical Faculty Clinical Research Ethics Committee has approved the trial (reference number: 2015/399), with anonymized results to be released in ClinicalTrials.gov. All patients will provide informed consent, which included an agreement for the use of anonymised data for research and SET.


Options:
A: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Genetic: single embryo transfer without aneuploidy screening | Arm Label: B; Type: EXPERIMENTAL; Interventions: Genetic: single embryo transfer with aneuploidy screening | Intervention Type: GENETIC; Name: single embryo transfer without aneuploidy screening; Assigned to Arm(s): A | Intervention Type: GENETIC; Name: single embryo transfer with aneuploidy screening; Assigned to Arm(s): B
B: Arm Label: PGT-A group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: comprehensive chromosome screening | Arm Label: Morphology group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: comprehensive chromosome screening; Assigned to Arm(s): PGT-A group
C: Arm Label: Control (no PGD); Type: N/A; Interventions: N/A | Arm Label: Case (PGD); Type: N/A; Interventions: N/A
D: Arm Label: Polar Body Biopsy; Type: EXPERIMENTAL; Interventions: Other: Polar Body Biopsy | Arm Label: No Polar Body Biopsy; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Polar Body Biopsy; Assigned to Arm(s): Polar Body Biopsy

Answer: B