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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06746129
Phase
PHASE3
Status
Recruiting
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Conditions

  • Infertility (IVF Patients)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • embryo transfer — PROCEDURE
    transfer of embryo(s) into the uterine cavity

Study Details

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 Dates

Start date
Sep 10, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
1,126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: cleavage-stage embryo transfer
    embryo(s) will be transferred on day 3 of embryo development (cleavage-stage embryo)
  • Active Comparator: blastocyst embryo transfer
    embryo(s) will be transferred on day 5-7 of embryo development (blastocyst-stage embryo)

Primary Outcome Measure

cumulative live birth per IVF cycle [ Time Frame: month 9 after embryo transfer ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston IVFBostonMassachusetts02451
Alan Penzias, MD
[email protected]
(888) 300-2483

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By research site
Boston IVF· Boston, MA

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