Ultrasound Guided Embryo Transfer: Abdominal Versus Transvaginal, a RCT

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00682071
First received: May 16, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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
Infertility
In Vitro Fertilization

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Abdominal Versus Transvaginal Ultrasound Guided Embryo Transfer: Results of a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • pregnancy rates for TAS and TVS ultrasound-guided ET groups [ Time Frame: August 2003 to June 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of time required for embryo transfer [ Time Frame: August 2003 to June 2007 ] [ Designated as safety issue: No ]
  • differences between transferring physicians [ Time Frame: August 2003 to June 2007 ] [ Designated as safety issue: No ]
  • multiple pregnancies [ Time Frame: August 2003 to June 2007 ] [ Designated as safety issue: No ]
  • ectopic pregnancy rates [ Time Frame: August 2003 to June 2007 ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: August 2003
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
transabdominal ultrasound (TAS) guided embryo transfer
2
transvaginal ultrasound (TVS) guided embryo transfer

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients undergoing assisted reproductive cycles at the University of Wisconsin REI Program

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682071

Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Steven R Lindheim, MD, MMM Fertility Specialists Medical Group
  More Information

No publications provided

Responsible Party: Steven R. Lindheim, MD, MMM, Fertility Specialists Medical Group, San Diego, CA
ClinicalTrials.gov Identifier: NCT00682071     History of Changes
Other Study ID Numbers: 2003-311, IRB# 2003-311 (UW), HSC# 2003-311 (UW), Grant: OB/GYN R&D, Funding # 133-FZ71
Study First Received: May 16, 2008
Last Updated: May 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Ultrasound-guided
embryo transfer
in-vitro fertilization

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014