Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer
Condition: Preimplantation Gentic Screening (PGS); In Vitro Fertilization (IVF); Preimplantation Genetic Diagnosis (PGD)
MeSH terms: Disease
Intervention: 24 Chromosome Aneuploidy Screening with Parental Support
Intervention description: Preimplantation Genetic Screening (PGS)
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: Female
Minimum age: 35 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Preimplantation Gentic Screening; PGS; In Vitro Fertilization; IVF; Preimplantation Genetic Diagnosis; PGD

Summary:

      Natera is recruiting patients for a research study evaluating pregnancy and implantation
      rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening
      (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy.

      Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited
      to participate in a randomized study.

      The purpose of this study is to determine whether PGS- testing of embryos created during IVF
      for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and
      implantation rates in patients when compared to patients whose embryos are not tested. PGS
      will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera.

      All subjects who qualify and enroll will receive discounted IVF medications (both TEST and
      CONTROL arms). If you become pregnant during the study, you will receive a small payment for
      providing information about your pregnancy and birth. If you are assigned to the TEST arm of
      the study you will receive free PGS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must agree to a follow-up visit at approximately 4-8 weeks gestation and a follow up
             phone call at 20 and 40 weeks gestation/livebirth. For patients assigned to the TEST
             group must agree to PGD testing and collection of buccal swab sample on newborn

          -  At least 10 eggs retrieved

          -  Must agree to use only Ferring products during stimulation

          -  Normal uterine cavity detected on hysterosalpingogram (HSG), saline infusion sonogram
             (SIS), or hysteroscopy

          -  Signed consent form

        Exclusion Criteria:

          -  FSH ≥10 IU/L within past year prior to screening

          -  2 or more previously failed IVF cycles

          -  Gestational or surrogate carrier, donor oocyte, donor sperm

          -  History of recurrent pregnancy loss (3 or more consecutive miscarriages)

          -  Severe male factor infertility defined as ejaculate sperm of < 1million sperm/ml, or
             sperm obtained through testicular biopsy

          -  Gender selection as primary indication

          -  Maternal disease that is not clinically stable and known to impact the ability to
             become pregnant or carry a pregnancy to term (lupus, chronic liver or kidney disease,
             body mass index (BMI) >35, uncontrolled hypertension, anti-phospholipid antibody,
             thrombophilia, insulin dependent diabetes)

          -  Refusal or inability to comply with the requirements of the Protocol for any reason,
             including scheduled clinic visits and laboratory tests

          -  Participation in any experimental drug study within 30 days prior to Screening

          -  Prior hypersensitivity to any of the protocol drugs

          -  Known history conveying increased risk for chromosome abnormality (beyond maternal
             age) or genetic disease in offspring