Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age

• ongoing pregnancy rate (past 2nd trimester). [ Time Frame: after 21 days, 20 weeks, and 7 month of treatment ] [ Designated as safety issue: No ]
  

• spontaneous abortions [ Time Frame: within 1st and 2nd trimester ] [ Designated as safety issue: No ]
  
• pregnancy [ Time Frame: one month for presence of fetal sac ] [ Designated as safety issue: No ]
  
• implantation [ Time Frame: first month, for presence of fetal sacs ] [ Designated as safety issue: No ]
  

Indications: Patients of advanced reproductive age wishing to receive preimplantation genetic screening in ART.

Objectives: To demonstrate that Preimplantation Genetic diagnosis (PGD) will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age (37-42) undergoing IVF.

Test Method: Preimplantation Genetic Screening through FISH Treatment: In Vitro Fertilization treatment. The resulting embryos of the test group will undergo embryo biopsy followed by PGD with FISH using a 10-probe test with "no result rescue".

Study Population: 978 infertile women undergoing ART Major Inclusions: Premenopausal infertile women wishing to conceive, aged 37 42 years, inclusive, regular menstrual cycles and screening early follicular phase FSH within normal limits.

Major Exclusions: Clinically significant systemic disease; any contraindication to pregnancy or carrying pregnancy to term; known ASRM Grade III or IV endometriosis; clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment; extrauterine pregnancy within 3 months prior to the beginning of OCP treatment; poor response in a previous ART cycle (≤ 3 oocytes retrieved); ≥ 3 prior, initiated, consecutive ART cycles without a clinical pregnancy; prior severe OHSS; TESA and TESE patients; patients carriers of chromosomal or genetic diseases.

Randomization: Eligible patients will be randomized in a 1:1 ratio to either:

Group A: Hatching "or" Group B: Hatching + PGS Study Procedures The study will be conducted on an outpatient basis. All pre-study screening assessments will be performed prior to treatment start.

Post-treatment Oocyte retrieval and embryology procedures will be Procedures performed according to the usual practice of the study center. Test Method Hatching, embryo biopsy, fixation and Fluorescence in-situ Hybridization (FISH) will be performed strictly in line with the methodology included in this protocol and only carried out by technicians certified by Reprogenetics.

Primary Endpoint: ongoing pregnancy rate (past 2nd trimester). Secondary Endpoints: implantation rate, pregnancy rate, miscarriage rate and live birth.