Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* ovulatory women undergoing infertility treatment
* maternal age below 36 years
* need for ICSI
* motile sperm: more than 1x1000000 sperm cells/ml
* both having a normal karyotype
B: 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.
C: Major Inclusion Criteria:

1. Age of female partner of \< 43 years
2. Normal day-three FSH level (\< 15 mIU/mL)
3. Normal uterine cavity
4. Sufficient ejaculated spermatozoa in male partner for ART
5. Maximum of one prior failed IVF cycle

Major Exclusion Criteria:

1. FSH level ≥ 15 mIU/mL
2. BMI greater than 32 kg/m2
3. Contraindication to gonadotropin stimulation
4. Unevaluated Ovarian mass
5. Need for surgical sperm removal
6. Any contraindication to undergoing in vitro fertilization
7. Age greater than 43 years
8. Presence of hydrosalpinges which communicate with the endometrial cavity
9. Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
D: Inclusion Criteria:

* infertility as an indication for IVF or ICSI;
* patients between their 36th and 41st birthdays (at time of signing ICF i.e. max 40years and 364days at the day of signing the informed consent);
* BMI range 18 to 30 kgs per m2;
* patients prepared to accept transfer of up to two embryos;
* absence of any type of genetic abnormality in the patient's personal and family history;
* normal karyotype (optional)

Exclusion Criteria:

* treatment involving donor oocytes (donor sperm is allowed subject to local practice and regulations and provided karyotype of the sperm donor is available and normal);
* menstrual irregularity (\<24 and \>35 days);
* three or more previous failed IVF or ICSI cycles, with the present partner. (Definition of a failed cycle: 'absence of a clinical pregnancy relating to a treatment with embryo transfer resulting from oocyte retrieval for the current intended pregnancy and with the current partner; the transfers include transfers of fresh and frozen within this treatment; clinical pregnancy is defined as the presence of a gestational sac at the earliest ultrasound and includes early clinical miscarriage, late miscarriage and clinically confirmed extrauterine pregnancy, and excludes preclinical miscarriage (biochemical pregnancy); -
* three or more clinical miscarriages;
* poor response in any previous cycle;
* low ovarian reserve (At least one of the following two features must be present: (1) a previous poor ovarian response (≤ 3 oocytes with a conventional stimulation 119 protocol); (2) an abnormal ovarian reserve test (i.e. AFC \< 5 follicles or AMH \< 0,5 ng/mL)\* (adapted from Ferraretti et al., 2011);
* cycles requiring surgical sperm recovery procedures;
* total asthenozoospermia and/or globozoospermia.
* any type of genetic abnormality or family history of genetic abnormality in subject or partner

Answer: B