Frozen Blastocyst Transfer Using Conventional Timing Versus Timing by Endometrial Receptivity Analysis

It has been proposed, that the receptivity status of the endometrium shifts among individual
women and that repeated implantation failure is ascribable to an endometrial factor in up to
25%. The endometrial receptivity analysis (ERA) is a diagnostic method that was developed
based on the unique genomic signature of the endometrium during the window of implantation
and classifies the endometrium as receptive, pre-receptive or post-receptive to guide embryo
transfer.

The purpose of this assessor-blind, randomized clinical study is to determine whether live
birth from vitrified/thawed euploid embryo transfer is improved when transfer is timed
according to endometrial receptivity analysis (ERA) results.

Approximately 800 women (n=400 in each arm) will be enrolled according to the
inclusion/exclusion criteria among patients of Shady Grove Fertility. Participants will
undergo a standard in vitro fertilization (IVF) cycle, followed by preimplantation genetic
screening (PGS) provided a high quality blastocyst is available. Participants with at least
one PGS normal (euploid) embryo will be randomized (assigned by chance, like the flip of a
coin) to one of two study groups. Women in both study arms will then undergo ERA testing and
neither the patients nor their treating physicians will know to which group the women have
been assigned to, or the ERA testing results. Up until this point there is no difference
between the study and control group. The investigational aspect of this trial is described as
follows: If the participant is assigned to the study arm, the single, euploid, frozen embryo
transfer (FET) during the subsequent cycle will be performed at the time indicated by the ERA
test results. If she is in the control arm, the embryo will be transferred according to our
standard FET protocol.

Patients enrolling in the study will receive PGS and ERA free of charge.

Inclusion Criteria:

1. Signed informed consent

2. Female age between 30 and 40 years and deemed likely by her physician, based on
ovarian reserve testing, to produce at least one euploid blastocyst via one
IVF/intracytoplasmatic sperm injection (ICSI) cycle

3. Having ≥ 1 euploid embryo available for embryo transfer

4. Standard eligibility criteria to undergo IVF and FET at Shady Grove Fertility Center.

Exclusion Criteria:

1. Known uterine factor impacting the endometrium

2. Use of surgically aspirated sperm for fertilization

3. Presence of any clinically relevant systemic disease that contraindicates assisted
reproductive technology.

4. Since the subject last had a live birth (if any), there have been more than two embryo
transfers that have not resulted in ongoing pregnancy

5. Body mass index >40 kg/m2 at screening

6. Recurrent pregnancy loss, defined as two or more clinical pregnancy losses without
live birth

7. Planned testing of embryos for single gene disorder(s) or structural chromosome
rearrangements

8. Currently breast feeding, pregnant, or contraindication to pregnancy