The goal of this randomized clinical trial is to compare frozen embryo transfer protocols in patients undergoing a second frozen embryo transfer (FET) after a unsuccessful first programmed FET cycle as a possible treatment for people undergoing infertility treatment. The purpose of this research study is to: * Determine if there is a difference between FET protocols in patients who require a second FET cycle. * Investigate if switching the FET protocol after a failed programmed cycle is beneficial for patients undergoing a second FET cycle. * Examine pregnancy outcomes including obstetrical and neonatal outcomes (if applicable) * Obtain uterine flexibility/stiffness measurements via transvaginal ultrasound prior to the embryo transfer procedure. This is called shear wave elastography. Participants will be randomized in their second FET transfer attempt to either another programmed protocol or a modified natural protocol.
This research study is studying if there is a difference in frozen embryo transfer protocols used (modified natural versus programmed) after a failed first programmed FET cycle, defined as either a negative pregnancy test or a biochemical loss, as a possible treatment for people undergoing infertility treatment and in vitro fertilization (IVF). Participants will be randomized, in a 1:1 ratio, in their second FET transfer attempt to either another programmed protocol or a modified natural protocol. Once randomized, participants will undergo routine FET monitoring based on their randomization allocation, transfer procedure and pregnancy monitoring as applicable. Additional ultrasound images will be obtained prior to the transfer procedure to assess the stiffness or flexibility of the uterus, called shear wave elastography. A participant blood sample and infant buccal swab will be collected for future research studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Participants are randomized to either another programmed FET Protocol vs. a modified natural FET protocol
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States
Reproductive Medicine Associates of New Jersey
Marlton, New Jersey, United States
Sustained implantation rate
presence of an intrauterine clinical pregnancy with fetal heart tones at 8 weeks gestational age
Time frame: approximately 6 weeks after embryo transfer
Biochemical Pregnancy Rate
Biochemical (positive serum beta human chorionic gonadotropin (bHCG) post transfer procedure)
Time frame: approximately 9 days after transfer
Biochemical pregnancy loss rate
serum bHCG level ≥ 5 milli-International unit (mIU/mL) after FET without any ultrasound evidence of pregnancy until serum bHCG is \< 5 mIU/mL
Time frame: typically 1 month post initial bHCG test
Clinical Pregnancy Rate
presence of an intrauterine gestational sac
Time frame: approximately 10 days after initial pregnancy test
Clinical Pregnancy Loss Rate
a pregnancy after FET that had at minimum ultrasound evidence of a gestational sac, but did not progress to a live birth and was not terminated nor was an ectopic pregnancy.
Time frame: approximately 2 months after FET procedure
Live Birth Rate
delivery of a live born infant greater than 24 weeks gestational age.
Time frame: approximately 16-32 weeks post discharge at 8 weeks gestational age
Rate of pregnancies of undetermined location and ectopic pregnancies
Pregnancies that are not intrauterine
Time frame: approximately 1-2 months post initial bHCG
Rate of maternal obstetrical outcomes and complications
mode of delivery, placental issues, preterm delivery
Time frame: approximately 40 weeks gestation
Rate of neonatal outcomes and complications
gestational age at delivery, birth weight, any complications
Time frame: approximately 40 weeks gestational age or after delivery of infant
Elastography Data
shear wave elastography measurements of the uterus
Time frame: prior to the embryo transfer procedure
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