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

Recruiting now · Phase 3

Conditions studied: Infertility (IVF Patients)

In brief

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.

Key facts

Study ID

NCT06746129

Run by

Beth Israel Deaconess Medical Center

People needed

1126

Starts

2025-09-10

Expected to finish

2031-06-30

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• autologous IVF cycle
• ≤5 zygotes on day 1 of development
• Fresh embryo transfer

You may not qualify if…

• Planned preimplantation genetic testing (PGT) of all embryos
• More than 2 previous IVF cycles
• History of recurrent pregnancy loss (≥3)
• Body mass index >40
• Presence of uterine factor infertility
• Planned gestational carrier
• Endometrial lining <6mm measured on the day of trigger
• Lupron-only trigger, elevated progesterone in the fresh cycle (≥1.5ng/ml)
• Delayed fertilization (>18 hours)
• Rescue intracytoplasmic sperm injection (following failed regular fertilization)
• Use of non-ejaculated sperm (testicular sperm extraction)
• Embryo transfer number outside American Society of Reproductive Medicine (ASRM) guidelines
• Cycle is converted to a cycle in which all embryos are frozen

Where it is running

• Boston IVF — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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