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

NCT06746129 | Recruiting Phase 3 DMC

• 2 other identifiers: 2024P00089235477
• Study Type: interventional
• Target: 1,126
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility (IVF Patients)

Keywords

infertility; in vitro fertilization; cleavage stage embryo; blastocyst; embryo transfer

Outcome Measures

Primary Outcomes (1)

• cumulative live birth per IVF cycle

  the number of live births resulting from transfer of all embryos obtained from one egg retrieval

  month 9 after embryo transfer

Secondary Outcomes (8)

• multiple pregnancy

  month 9 after embryo transfer

• number of involved procedures

  month 9 after embryo transfer

• ectopic pregnancy

  month 9 after embryo transfer

• live birth rate/fresh embryo transfer

  month 9 after embryo transfer

• adverse perinatal outcomes (stillbirth, preterm birth)

  month 9 after embryo transfer

Other Outcomes (3)

• cumulative live birth rate among participants with 1-2 vs 3-5 zygotes

  month 9 after embryo transfer

• cumulative live birth rate among participants age <38 and ≥ 38 years

  month 9 after embryo transfer

• cumulative live birth rate for poor versus good quality embryos in patients undergoing SET

  month 9 after embryo transfer

Study Arms (2)

cleavage-stage embryo transfer

ACTIVE COMPARATOR

embryo(s) will be transferred on day 3 of embryo development (cleavage-stage embryo)

Procedure: embryo transfer

blastocyst embryo transfer

ACTIVE COMPARATOR

embryo(s) will be transferred on day 5-7 of embryo development (blastocyst-stage embryo)

Procedure: embryo transfer

Interventions

embryo transfer PROCEDURE

transfer of embryo(s) into the uterine cavity

blastocyst embryo transfer; cleavage-stage embryo transfer

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• 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

Study Sites (1)

Boston IVF

Boston, Massachusetts, 02451, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Werner Neuhausser, MD PhD

  Beth Israel Deaconess Medical Center/Harvard Medical School

  PRINCIPAL INVESTIGATOR

• Dustin Rabideau, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatrice Duvert

CONTACT

617-975-7632; bduvert@bidmc.harvard.edu

Werner Neuhausser, MD PhD

CONTACT

wneuhaus@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 24, 2024
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)