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Day 3 Versus Day 5 Embryo Transfer in IVF Patients With Few Embryos

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 44
Healthy Volunteers: f
View:

• First autologous IVF cycle

• ≤5 zygotes on day 1 of development

• Fresh embryo transfer

Locations
United States
Massachusetts
Boston IVF
RECRUITING
Boston
Contact Information
Primary
Beatrice Duvert
bduvert@bidmc.harvard.edu
617-975-7632
Backup
Werner Neuhausser, MD PhD
wneuhaus@bidmc.harvard.edu
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2031-06-30
Participants
Target number of participants: 1126
Treatments
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)
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, Weill Medical College of Cornell University, Massachusetts General Hospital (MGH), Yale University, Columbia University, Boston IVF, Brigham and Women's Hospital, University of Michigan, UCSF Center for Reproductive Health, Patient-Centered Outcomes Research Institute, University of Pennsylvania
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov