Single Embryo Transfer of a Euploid Embryo Versus Double Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This study seeks to compare the pregnancy and delivery rates of patients who undergo a single
      embryo transfer, when the embryo has been tested and determined to be chromosomally normal,
      with pregnancy and delivery rates of patients who undergo a two (2) embryo transfer of
      untested embryos.
    

Detailed description: 
      This study will recruit patients from the NJ/NY/CT/eastern PA area only.

      Twin and higher-order multiple pregnancies are the most common and most significant
      complication of pregnancies conceived through assisted reproductive technologies (ART). Twin
      rates in in vitro fertilization (IVF) cycles are approximately 30%. These pregnancies have
      increased complications for both the mother and the babies. A singleton, one baby, is the
      safest outcome for an IVF cycle. The surest way to reduce the risk of multiple births in IVF
      cycles is to transfer fewer embryos. Prior studies on single embryo transfer (SET) have shown
      decreased pregnancy rates because of the difficulty in selecting which embryo to transfer.
      Being chromosomally normal is necessary for the delivery of a healthy baby. The investigators
      are now able to screen all 24 chromosomes of an embryo with greater than 97% accuracy within
      four hours, allowing for a fresh embryo transfer of a tested embryo, using Comprehensive
      Chromosome Screening (CCS). This study seeks to show that the transfer of a single CCS-normal
      embryo will result in delivery rates equal to those resulting from a two embryo transfer, the
      current standard of care in IVF.

      Patients will undergo IVF according to the protocol recommended by their primary doctor. On
      the day of egg retrieval, all mature eggs will be fertilized by intracytoplasmic sperm
      injection (ICSI) per routine laboratory protocol. Embryos will then be cultured out to day 5
      per routine laboratory procedure. The embryos will be assessed by the embryologist on day 5
      to determine if the patient is a candidate for a fresh transfer. Patients who are a candidate
      for fresh transfer will be randomized into either the single embryo transfer of a
      chromosomally normal embryo group or the double, untested embryo group. Patients will have a
      50:50 chance of being in the single or double embryo transfer group. Embryos in the single
      embryo group will undergo biopsy for CCS and patients will then undergo transfer of the
      morphologically best, chromosomally normal embryo. Additional embryos will be cryopreserved.
      Patients in the double embryo transfer group will undergo a two embryo transfer. Additional
      embryos will be cryopreserved. If patients are not a candidate for a fresh transfer
      (potentially because of endometrial lining development, risk of ovarian hyperstimulation
      syndrome, or embryos that are not suitable for biopsy on day 5), they will still be
      randomized into either the single or double embryo transfer group. Patients in the single
      embryo transfer group will have all embryos biopsied for CCS prior to being frozen. Patients
      will then immediately undergo a synthetic frozen embryo transfer cycle in accordance with
      their randomization. Patients in the double embryo transfer group will have their embryos
      frozen and will then immediately prepare for a synthetic frozen embryo transfer cycle in
      accordance with their randomization. Any patient who does not become pregnant during their
      fresh transfer cycle will immediately undergo a synthetic frozen embryo transfer cycle in
      accordance with their original randomization.

      All clinical follow up will be per routine regarding pregnancy testing, early pregnancy
      monitoring and subsequent transfer of care to the patient's obstetrician. If clinical
      miscarriage occurs, cells from the products of conception will be collected, if possible, and
      submitted for genetic analysis. If the pregnancy progresses to delivery, a buccal swab (small
      swab touched to the inside of the baby's cheek) will be collected and submitted for genetic
      analysis.
    

Intervention name(s): Single Embryo Transfer; Double embryo transfer
Intervention type(s): Other; Other
Intervention description(s): single embryo transfer of a chromosomally normal embryo; two (2) embryo transfer of untested embryos
Other intervention name(s): pre-implantation genetic diagnosis (PGD); in-vitro fertilization (IVF); two embryo transfer; in-vitro fertilization (IVF)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: embryo transfer; in-vitro fertilization (IVF); pre-implantation diagnosis (PGD); infertility; single embryo transfer; two embryo transfer; double embryo transfer