1126 Participants Needed

Embryo Transfer Timing for Infertility

(PRECiSE Trial)

MB
WN
BD
WN
Overseen ByWerner Neuhausser, MD PhD
Age: 18 - 65
Sex: Female
Trial Phase: Phase 3
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

WN

Werner Neuhausser, MD PhD

Principal Investigator

Beth Israel Deaconess Medical Center/Harvard Medical School

DR

Dustin Rabideau, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for women undergoing their first IVF cycle with 5 or fewer fertilized eggs (zygotes) on the first day of development, who are planning to have a fresh embryo transfer. It's not specified who can't join because the exclusion criteria are missing.

Inclusion Criteria

This is my first time trying IVF with my own eggs.
I am undergoing a fresh embryo transfer.
I had 5 or fewer fertilized eggs after one day of development.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo embryo transfer on either day 3 (cleavage-stage) or day 5-7 (blastocyst-stage) of embryo development

1 week

Follow-up

Participants are monitored for pregnancy outcomes and safety for 6 months after embryo transfer

6 months

Extended Follow-up

Participants are monitored for pregnancy outcomes until delivery if pregnancy is achieved

9 months

What Are the Treatments Tested in This Trial?

Interventions

  • Embryo Transfer
Trial Overview The study compares two timings for transferring embryos in IVF: one group has embryos transferred at an advanced stage (blastocyst) after growing for 5-7 days, and another group at an earlier stage (8-cell) after just 3 days. The goal is to see which leads to better pregnancy outcomes and patient satisfaction.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: cleavage-stage embryo transferActive Control1 Intervention
Group II: blastocyst embryo transferActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Brigham and Women's Hospital

Collaborator

Trials
1,694
Recruited
14,790,000+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Massachusetts General Hospital (MGH)

Collaborator

Trials
1
Recruited
1,100+

Yale School of Medicine

Collaborator

Trials
5
Recruited
2,100+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

Boston IVF

Collaborator

Trials
21
Recruited
21,400+
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