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Ultrasound Guided Embryo Transfer: Abdominal Versus Transvaginal, a RCT

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT00682071
Collaborator
(none)
224
Enrollment
46
Duration (Months)

Study Details

Study Description

Brief Summary

Ultrasound (US) guided embryo transfer (ET) appears to improve pregnancy outcomes in IVF-ET. Most reports are done using a transabdominal (TAS) approach, in contrast to a transvaginal ultrasound (TVS) which does not require a full bladder. We sought to determine if either approach was better with respect to clinical outcomes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    224 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Abdominal Versus Transvaginal Ultrasound Guided Embryo Transfer: Results of a Randomized Clinical Trial
    Study Start Date :
    Aug 1, 2003
    Actual Primary Completion Date :
    Jun 1, 2007
    Actual Study Completion Date :
    Jun 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    1

    transabdominal ultrasound (TAS) guided embryo transfer
    2

    transvaginal ultrasound (TVS) guided embryo transfer

    Outcome Measures

    Primary Outcome Measures

    1. pregnancy rates for TAS and TVS ultrasound-guided ET groups [August 2003 to June 2007]

    Secondary Outcome Measures

    1. Length of time required for embryo transfer [August 2003 to June 2007]

    2. differences between transferring physicians [August 2003 to June 2007]

    3. multiple pregnancies [August 2003 to June 2007]

    4. ectopic pregnancy rates [August 2003 to June 2007]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All patients undergoing assisted reproductive cycles including autologous IVF, oocyte donation, and frozen embryo transfer (FET) cycles
    Exclusion Criteria:
    • Cases of severe ovarian hyper-stimulation requiring embryo cryopreservation and gestational surrogate cycles

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: Steven R Lindheim, MD, MMM, Fertility Specialists Medical Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT00682071
    Other Study ID Numbers:
    • 2003-311
    • IRB# 2003-311 (UW)
    • HSC# 2003-311 (UW)
    • Grant: OB/GYN R&D
    • Funding # 133-FZ71
    First Posted:
    May 22, 2008
    Last Update Posted:
    Oct 5, 2015
    Last Verified:
    May 1, 2008
    Keywords provided by University of Wisconsin, Madison
    Ultrasound-guided
    embryo transfer
    in-vitro fertilization
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Oct 5, 2015