NCT06746129 Cleavage-stage Versus Blastocyst-stage Embryo Transfer in IVF Patients With Few Embryos
| NCT ID | NCT06746129 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Infertility (IVF Patients) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,126 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,126 participants in total. It began in 2025-09-10 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * autologous IVF cycle * ≤5 zygotes on day 1 of development * Fresh embryo transfer Exclusion Criteria: * 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
Contact & Investigator
Werner Neuhausser, MD PhD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center/Harvard Medical School
Frequently Asked Questions
Who can join the NCT06746129 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 44 Years, studying Infertility (IVF Patients). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06746129 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,126 participants.
Is NCT06746129 currently recruiting?
Yes, NCT06746129 is actively recruiting participants. Contact the research team at bduvert@bidmc.harvard.edu for enrollment information.
Where is the NCT06746129 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06746129 clinical trial?
NCT06746129 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Werner Neuhausser, MD PhD at Beth Israel Deaconess Medical Center/Harvard Medical School. The trial plans to enroll 1,126 participants.