Cleavage-stage Versus Blastocyst-stage Embryo Transfer in IVF Patients With Few Embryos

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorBeth Israel Deaconess Medical Center

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

Qualifiers

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

Treatments tested in this trial

  • embryo transfer

Treatment groups

1,126 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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