An interventional study of FET Protocol in Infertility, Female, sponsored by Reproductive Medicine Associates of New Jersey. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 53 Years. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Reproductive Medicine Associates of New Jersey · Not applicable, Interventional, and Treatment
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:
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 9 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Reproductive Medicine Associates of New Jersey is the lead sponsor of 54 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Major Inclusion Criteria: The following are major inclusion criteria:
Major Exclusion Criteria: The following are exclusion criteria:
Patients in this arm of the study will proceed with another programmed FET protocol which involves taking exogenous estrogen by mouth to stimulate the uterine lining to grow and develop. Once the lining has reached ≥ 7 mm and an endometrial pattern of type 1 or type 2, intramuscular progesterone in oil (50mg/ml daily) will be started at 8am on the morning that progesterone is initiated and continued per routine.
Other: FET Protocol
Following development of at least one dominant follicle and endometrial proliferation ≥ 7 mm during cycle monitoring, patient will undergo administration of human chorionic gonadotropin (hCG) trigger shot followed by initiation of vaginal progesterone administration in accordance with institutional protocols.
Other: FET Protocol
Participants are randomized to either another programmed FET Protocol vs. a modified natural FET protocol
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
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Reproductive Medicine Associates of New Jersey