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PooR Embryo Yield Cleavage Stage Versus blaStocyst Embryo Transfer (PRECiSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03764865
Recruitment Status : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Boston IVF
Information provided by (Responsible Party):
Werner Neuhausser, Beth Israel Deaconess Medical Center

Brief Summary:
The purpose of this study is to compare IVF outcomes between day 3 and day 5 embryo transfer in patients with five or fewer embryos in a fresh embryo transfer in vitro fertilization (IVF) cycle. Information derived from this trial would allow us to maximize the chances of success for these patients undergoing IVF.

Condition or disease Intervention/treatment Phase
Infertility Procedure: day 3 uterine transfer Procedure: day 5 uterine transfer Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: non-inferiority
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Day 3 vs Day 5 Embryo Transfer for Patients With Low Embryo Numbers Going Through in Vitro Fertilization
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: day 3 embryo transfer Procedure: day 3 uterine transfer
uterine transfer of embryo on day 3 after fertilization (cleavage stage)

Experimental: day 5 embryo transfer Procedure: day 5 uterine transfer
uterine transfer of embryo on day 5 after fertilization (blastocyst stage)




Primary Outcome Measures :
  1. live birth [ Time Frame: 9 months ]
    defined as delivery of a live born infant ≥22 weeks of gestation


Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 14 days ]
    defined by confirmation of a gestational sac on ultrasound

  2. Ongoing pregnancy [ Time Frame: 9 months ]
    defined by ultrasound confirmation of a gestational sac with at least one fetal pole with a fetal heartbeat

  3. Multiple pregnancy [ Time Frame: 9 months ]
    defined as twins or higher-order gestations

  4. Time to pregnancy/live birth [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First autologous IVF cycle
  • Written, informed consent

Exclusion Criteria:

  • Planned gestational carrier
  • Planned donor egg
  • Morbid obesity: BMI >40
  • History of recurrent pregnancy loss (≥2 spontaneous abortions)
  • Presence of uterine factor infertility
  • Treatment plan includes embryos cultured 'out of protocol'
  • Planned preimplantation genetic testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764865


Contacts
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Contact: Werner Neuhausser, MD PhD (646) 510-4825 wneuhaus@bidmc.harvard.edu
Contact: Denis Vaughan, MD (857) 264-7661 dvaughan@bostonivf.com

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Boston IVF
Investigators
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Principal Investigator: Werner Neuhausser, MD PhD Beth Israel Deaconess Medical Center
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Werner Neuhausser, Instructor in Obstetrics, Gynecology and Reproductive Biology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03764865    
Other Study ID Numbers: 2018P000530
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Werner Neuhausser, Beth Israel Deaconess Medical Center:
cleavage embryo
blastocyst
embryo transfer
in vitro fertilization
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female