Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Single Centre Randomised Controlled Study Into the Segmentation of Preimplantation Genetic Diagnosis (PGD) Treatment by Comparing Cumulative Pregnancy Rates Following Cryopreservation of All Genetically Transferable Embryos After PGD, Compared to Fresh Embryo Transfer Cumulative With Frozen Embryo Transfer of Genetically Transferable Embryos.
Brief Summary: A single centre observational study into the segmentation of preimplantation genetic diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation of all genetically transferable embryos after PGD, compared to fresh embryo transfer cumulative with frozen embryo transfer of genetically transferable embryos.The primary aim of the study is to assess the feasibility and effectiveness of segmentation in terms of pregnancy rates. The secondary aim is to assess the logistic advantage of segmentation in PGD cycles.

Experimental questions

1. Is the cumulative live birth rate rate of a single PGD treatment when all genetically transferable embryos are cryopreserved by vitrification prior to consecutive in utero transfer in unstimulated cycles, superior to PGD treatment with fresh embryo transfer cumulative with transfer of supernumerary cryopreserved embryos?
2. Does the technique of segmentation allow better planning of DNA amplification and genetic analysis?

Design The proposed design is a pragmatic, prospective randomised controlled trial


Options:
A: Inclusion Criteria:

* 1st, 2nd or 3rd cycle of PGD in which embryo transfer was performed
* Indications for PGD: monogenic indications and X-linked disorders with a 25-50% risk of transmission and that are not associated with reduced ovarian response
* Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
* Regular menstrual cycles of 21-35 days, presumed to be ovulatory.

Exclusion Criteria:

* POLYCYSTIC OVARIAN SYNDROME (Rotterdam criteria \*)

  \* At least two of the following three features: (i) Oligo- and/or anovulation (ii) Clinical and/or biochemical signs of hyperandrogenism (iii) Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumours, Cushing's syndrome)
* Poor responders (Bologna criteria \*\*)

  \* \* At least two of the following three features: (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response (POR); (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles, or anti-Mullerian hormone (AMH) 0.5-1.1 ng/ml).
* Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
* anticipated high response: AMH \>5.0 ng/ml or AFC \>20
* Endometriosis ≥ grade 3
* Age \> 40 years and 364 days
B: Inclusion Criteria:

* Women \[18 - 40\[years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
* Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
* Absence of any medical condition in which pregnancy is contraindicated
* Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection (ICSI) will be allowed during this trial
* Body mass index 18 to 35 kg/m2, inclusive
* Able to understand the study
* Affiliation with a social security scheme
* Dated and signed inform consent

Exclusion Criteria:

* Altered ovarian reserve (Day3: FSH \>12 UI/l; AMH\<1,0 ng/ml; AFC\<8)
* History or presence of tumours of the hypothalamus or pituitary gland
* Presence of non isolated uni- or bilateral hydrosalpinx
* Abnormal gynaecological bleeding of undetermined origin
* Contraindication to being pregnant and/or carrying a pregnancy to term
* Known infection with human immunodeficiency virus, active hepatitis B or C virus in the female or male partner
* History or presence of ovarian, uterine or mammary cancer
* Known allergy or hypersensitivity to human gonadotropin preparations or to compounds that are structurally similar to any of the other medications administered during the trial
* Substance abuse that would interfere with trial conduct, as determined by the investigator
* Use of testicular or epididymal sperm
* Pregnant patient, nursing patient
* Participation in another ART clinical trial within the past 30 days
* Women who have risk to develop severe ovarian hyperstimulation syndrome (OHSS) during controlled ovarian stimulation (COS) defined as ≥ 18 follicles measuring 10 - 14 mm on the day of triggering
* Women with less than 3 follicles ≥ 15 mm on the triggering day or the day before the triggering
* Women with premature progesterone elevation during COS ( ≥1.5 ng/ml)
* Women with uterine polyps diagnosed during COS
* Participation with another interventional study involving human subjects
C: Inclusion Criteria:

1. Female patient 18 to 40 years of age seeking their first IVF treatment.
2. Cycle day 3 FSH less than 10.0 IU/l.
3. More than 15 antral follicles observed on ultrasound.

Exclusion Criteria:

1. Failure to follow the protocol.
2. Embryo biopsy.
3. Any prior IVF cycle(s).
D: Inclusion Criteria (pre-stimulation):

* Age up to 42 years

Exclusion Criteria (pre-stimulation):

* MESA and TESE patients
* At least one partner carrier of a chromosomal abnormality
* Egg donor cycle (sperm donor is acceptable)
* Gender selection cycles
* Thaw cycles
* Any patient who cannot have a fresh embryo transfer
* FSH above 12 or AMH less than 1

Answer: A