Embryo Transfer Timing for Infertility

(PRECiSE Trial)

Overseen By Werner Neuhausser, MD PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Genetic testing, Pregnancy loss, Obesity, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

1126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal timing for embryo transfer during IVF (in vitro fertilization) to enhance pregnancy outcomes and patient satisfaction. It compares transferring embryos at the 8-cell stage (3 days after fertilization) with transferring them at the blastocyst stage (5-7 days after fertilization). The trial aims to guide decisions for women with 5 or fewer embryos, potentially reducing anxiety and improving treatment planning. Women undergoing their first IVF cycle with 5 or fewer embryos and not planning genetic testing may be suitable candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both early-stage (day 3) and later-stage (day 5) embryo transfers are generally safe. Studies indicate that transferring embryos on day 3 can lead to successful outcomes similar to those on day 5, with no major safety concerns reported for day 3 transfers.

For later-stage transfers, evidence suggests that transferring embryos on day 5 results in higher pregnancy success rates compared to day 6. This indicates that transferring embryos at this stage might be a good option without significant safety issues. Overall, both methods are safe and commonly used in IVF treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the timing of embryo transfer in treating infertility, specifically examining whether transferring embryos at the cleavage stage (day 3) or the blastocyst stage (days 5-7) leads to better outcomes. Unlike typical protocols that might not differentiate between these stages, this trial seeks to optimize the success rate by pinpointing the most effective timing for implantation. By potentially improving the chances of successful pregnancy, this research could refine and enhance current infertility treatment practices.

What evidence suggests that this trial's embryo transfer timings could be effective for infertility?

This trial will compare the effectiveness of two embryo transfer timings: cleavage-stage embryo transfer on Day 3 and blastocyst-stage embryo transfer on Days 5-7. Studies have shown that transferring embryos at either the early stage (Day 3) or the later stage (Days 5-7) can effectively achieve pregnancy. Research indicates that early-stage transfers can result in birth rates similar to those of later-stage transfers, especially when few embryos are available. Some studies suggest that early-stage transfers can be as effective as later-stage ones, making them a viable option for those with fewer embryos. Conversely, later-stage transfers have been linked to a higher chance of embryo implantation, potentially increasing the likelihood of pregnancy. Both methods have shown positive results, and the choice may depend on individual circumstances and preferences. ^{1 5 6 7 8}

Who Is on the Research Team?

Werner Neuhausser, MD PhD

Principal Investigator

Beth Israel Deaconess Medical Center/Harvard Medical School

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?

Group I: cleavage-stage embryo transfer Active Control 1 Intervention

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

Group II: blastocyst embryo transfer Active Control 1 Intervention

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

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3811723/

Comparison of the clinical outcomes of day 4 and 5 embryo ... The pregnancy outcomes of day 4 ET (40.7%) were similar to those of day 5 ET (44.6%). The implantation rate of day 5 ET (24.2%) was significantly higher than ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666334124001119

Fresh vs. frozen: pregnancy outcomes and treatment ... This study aims to compare pregnancy outcomes in patients who underwent a fresh single blastocyst ET with patients undergoing embryo freeze-all followed by ...

3. bmj.com bmj.com/content/388/bmj-2024-081474

Frozen versus fresh embryo transfer in women with low ... Fresh embryo transfer may be a better choice for women with low prognosis in terms of live birth rate compared with a freeze-all strategy.

4. rbej.biomedcentral.com rbej.biomedcentral.com/articles/10.1186/s12958-021-00824-y

Sequential cleavage and blastocyst embryo transfer and IVF ... The current systematic review demonstrates that sequential cleavage and blastocyst embryo transfer improve the clinical pregnancy rate over conventional ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11622402/

Effect of day 5 or 6 blastocyst embryo transfer on ... Higher rates of clinical pregnancy were observed in women who underwent embryo transfers performed on day 5 compared to those on day 6.

6. nature.com nature.com/articles/s41598-025-17793-6

Day 6 vitrified blastocyst transfer on day 5 vs. ... Our findings suggest that transfer timing may be less critical when embryo quality is high.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1028455923000244

Comparing the effect of sequential embryo transfer versus ... Results demonstrated that sequential embryo transfer on day 3 and day 5 compared to double blastocyst transfer on day 5 significantly increased implantation ...

8. ferty9.com ferty9.com/blog/success-rates-of-5-day-blastocyst-transfer

Blastocyst IVF Success: Your Guide to Day 5 Embryo ... Compared to earlier-stage transfers, day 5 blastocyst transfers had higher success rates, better embryo growth, and a higher chance of ...