About this trial
Infertility affects more than 6 million women the United States and is a major life event that results in a wide range of socio-cultural, emotional, physical and financial problems. The most successful treatment for infertility, in-vitro fertilization (IVF), fertilizes a woman's eggs with her partner's sperm in a culture dish and transfers the resulting embryos into the uterus. Most of the time, prior to being transferred, embryos are grown in the dish for 5-7 days after which some of them reach an advanced stage (blastocyst stage). This has several advantages such as a lower chance of a multiple pregnancies (twins, triplets etc.) after transfer and fewer transfer procedures. However, it is possible that embryos would survive better if transferred into the uterus at the 8-cell stage after growing them for only 3 days. Thus, when patients only have a small number of embryos they and their physicians face the difficult choice when to transfer because there are currently no studies available to guide this decision.
This randomized controlled trial is comparing pregnancy outcomes and patient satisfaction of poor prognosis patients with 5 or fewer embryos undergoing either transfer of an advanced (blastocyst) or an 8-cell embryo.
This study will provide the data for the development of guidelines for IVF providers to make evidence-based decisions when to transfer embryos in poor prognosis IVF patients, reduce patients' anxiety regarding cycle cancellation and improve patient counseling, which will increase patients' ability to participate in the development of their treatment plan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
autologous IVF cycle
≤5 zygotes on day 1 of development
Fresh embryo transfer
Disqualifiers
Planned preimplantation genetic testing (PGT) of all embryos
More than 2 previous IVF cycles
History of recurrent pregnancy loss (≥3)
Body mass index >40
Trial design
Parallel
Treatments tested in this trial
embryo transfer
Procedure/Surgerytransfer of embryo(s) into the uterine cavity
Treatment groups
Trial outcomes
Primary outcomes
cumulative live birth per IVF cycle
the number of live births resulting from transfer of all embryos obtained from one egg retrieval
Secondary outcomes
multiple pregnancy
rate of twin, triplet and higher order pregnancies
number of involved procedures
number of embryo transfers necessary to achieve pregnancy and procedures to treat pregnancy complications
ectopic pregnancy
rate of pregnancies outside the uterus (Fallopian tube, cervix, ovary, abdomen)
live birth rate/fresh embryo transfer
rate of birth of a live baby per embryo transfer performed
Other outcomes
cumulative live birth rate among participants with 1-2 vs 3-5 zygotes
subgroup analysis of the cumulative live birth rate per egg retrieval in patients with very low (1-2) and higher number of embryos (3-5)
cumulative live birth rate among participants age <38 and ≥ 38 years
subgroup analysis of the cumulative live birth rate per egg retrieval in patients \<38 and ≥ 38 years
cumulative live birth rate for poor versus good quality embryos in patients undergoing SET
subgroup analysis of the cumulative live birth rate per egg retrieval in patients undergoing SET with poor versus good quality embryos
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
Brigham and Women's Hospital
Collaborator
Boston IVF
Collaborator
Columbia University
Collaborator
Weill Medical College of Cornell University
Collaborator
Mayo Clinic
Collaborator
University of Michigan
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Massachusetts General Hospital (MGH)
Collaborator
Yale University
Collaborator
UCSF Center for Reproductive Health
Collaborator
University of Pennsylvania
Collaborator