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
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, see Learn About Clinical Studies.

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 October 19, 2014