Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective, Multi-center, Randomized Controlled Trial Comparing Pregnancy Outcomes Following Selection and Single Embryo Transfer (SET) Based on Preimplantation Genetic Screening (PGS) by Next Generation Sequencing (NGS) Versus Standard Morphological Assessment
Brief Summary: The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All embryos will be vitrified and a single embryo transfer (SET) will be performed with either screened or unscreened embryos depending on randomization.


Options:
A: Inclusion Criteria:

1. Maximum of one (1) prior failed IVF cycle (a failed cycle is any cycle that did not deliver. Pregnancy losses are failed cycles. Ok to participate as a recipient in an egg donor cycle.)
2. Female partner less than 43 years old at time of onset of IVF cycle
3. Maximum prior day 3 follicle stimulation hormone (FSH) level of 12 (in RMA NJ laboratory)
4. Minimum anti-mullerian hormone (AMH)of 1.2 within 1 year
5. Normal uterine cavity demonstrated by saline sonogram, hysterosalpingogram or hysteroscopy within 1 year.
6. Male partner with greater than 100,000 total motile spermatozoa. Donor sperm ok.
7. Body Mass Index (BMI) less than or equal to 30 kg/m2.

Exclusion Criteria:

1. Diagnosis of chronic anovulation (cycles typically longer than 90 days)
2. Diagnosis of endometrial insufficiency- prior cycle with endometrial thickness less than 6mm, abnormal endometrial echotexture, persistent endometrial fluid.
3. Clinical indication of aneuploidy screening (i.e. history of loss of chromosomally abnormal pregnancies)
4. Clinical indication for PGD for single-gene disorder (i.e. PGD is needed to select against the transfer of embryos affected with a specific condition)
5. Use of testicular aspiration or biopsy procedures to obtain sperm
6. Unevaluated ovarian mass or surgically confirmed stage IV endometriosis
7. Presence of hydrosalpinges which communicate with the endometrial cavity
8. Any contraindication to undergoing in vitro fertilization
B: 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)
C: Inclusion Criteria:

* Patient undergoing IVF
* At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development

Exclusion Criteria:

* History of more than two prior implantation failure following IVF
* History of more than one miscarriage of viable pregnancy
* One or both partners known to be carrier(s) of a chromosomal abnormality
* Known genetic carrier couple and/or one or both partners carrier of a known autosomal dominant disorder
* Any other non-study related preimplantation genetic testing
* Use of donor oocytes
* Use of gestational carrier (surrogate or donor egg recipient).
* Severe oligospermia (\<1,000,000 sperm/ml); Surgical Sperm Retrieval for reasons other than post-vasectomy and CAVD
* Low ovarian reserve with (FSH) \>10 IU/L on day 2-4 of a prior menstrual cycle and/or (AMH) \<7 pmol/L (or \<1 ng/ml)
* Gender selection cycles
* Concurrent participation in another clinical trial
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: C