Ultrasound Guided Embryo Transfer: Abdominal Versus Trans... | NCT00682071

Studies
Ultrasound Guided Embryo Transfer: Abdominal Versus Transvaginal, a RCT

NCT00682071

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Oct 5, 2015Estimated

Enrollment

224Actual

Phase

Not provided

Conditions

Infertility
in Vitro Fertilization

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

May 16, 2008

First Submission Date that Met QC Criteria

May 16, 2008

First Posted Date

May 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2015

Last Update Posted Date

Oct 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

224Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		transabdominal ultrasound (TAS) guided embryo transfer
2		transvaginal ultrasound (TVS) guided embryo transfer

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pregnancy rates for TAS and TVS ultrasound-guided ET groups		August 2003 to June 2007

Secondary Outcomes

Measure	Description	Time Frame
Length of time required for embryo transfer		August 2003 to June 2007
differences between transferring physicians		August 2003 to June 2007
multiple pregnancies

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven R Lindheim, MD, MMM	Fertility Specialists Medical Group	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
IRB# 2003-311 (UW)
HSC# 2003-311 (UW)
Grant: OB/GYN R&D
Funding # 133-FZ71