Primary outcome: Primary: The Percentage of Patients With a Live Birth — 45; 65 Participants
Study Design & Population
Study type
Interventional
Phase
N/A
Interventions
comprehensive chromosome screening (Procedure)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Antalya IVF
Primary completion
Feb 2018
Outcome Measures
Outcome
Result
p-value
PRIMARY The Percentage of Patients With a Live Birth
45; 65
—
SECONDARY The Percentage of Patients With a Clinical Pregnancy
49; 76
—
SECONDARY The Percentage of Pregnancies That Miscarried
3; 11
—
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.
Eligibility Criteria
Inclusion Criteria
Patient-couples eligible for inclusion in the trial must satisfy the following criteria; female age of ≤35 years, female body mass index (BMI) of ≥18 or ≤35 kg/m2, antral follicle count (AFC) of ≥10, normo-ovulatory, intend to use autologous oocytes, and have ≥2 blastocysts with a morphological score of 2BB on day 5 of embryo development
Exclusion Criteria
Patient couples will be excluded from the trial for the following reasons, patients with drug contraindications, patients with pathophysiology unrelated to reproduction, patients with intrauterine pathophysiologies, patients with no blastocysts, patients with <2 blastocysts with a morphological score of 2BB.
Data sourced from ClinicalTrials.gov (NCT03095053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.