RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-10
Study Completion:2031-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06746129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * First autologous IVF cycle
  2. * ≤5 zygotes on day 1 of development
  3. * Fresh embryo transfer
  1. * Planned preimplantation genetic testing (PGT)
  2. * History of recurrent pregnancy loss (≥3)
  3. * Body mass index \>40
  4. * Presence of uterine factor infertility
  5. * Planned gestational carrier
  6. * Endometrial lining \<6mm measured on the day of trigger
  7. * Lupron-only trigger, elevated progesterone in the fresh cycle (≥1.5ng/ml)
  8. * Delayed fertilization (\>18 hours)
  9. * Rescue intracytoplasmic sperm injection (following failed regular fertilization)
  10. * Use of non-ejaculated sperm (testicular sperm extraction)
  11. * Embryo transfer number outside American Society of Reproductive Medicine (ASRM) guidelines
  12. * Cycle is converted to a cycle in which all embryos are frozen

Contacts and Locations

Study Contact

Beatrice Duvert
CONTACT
617-975-7632
bduvert@bidmc.harvard.edu
Werner Neuhausser, MD PhD
CONTACT
wneuhaus@bidmc.harvard.edu

Principal Investigator

Werner Neuhausser, MD PhD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center/Harvard Medical School
Dustin Rabideau, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Boston IVF
Boston, Massachusetts, 02451
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Werner Neuhausser, MD PhD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center/Harvard Medical School
  • Dustin Rabideau, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-10
Study Completion Date2031-06-30

Study Record Updates

Study Start Date2025-09-10
Study Completion Date2031-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Infertility (IVF Patients)