Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine... | NCT00816387

Studies
Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle

NCT00816387

Sponsor

IRCCS Burlo Garofolo

Status

Completed

Last Update Posted

Dec 3, 2010Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Insemination, Artificial

Interventions

Fallopian tube sperm perfusion
Intrauterine insemination using standard catheter

Countries

Italy

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

Mar 2009

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

Oct 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 31, 2008

First Submission Date that Met QC Criteria

Dec 31, 2008

First Posted Date

Jan 1, 2009Estimated

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

Dec 2, 2010

Last Update Posted Date

Dec 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to evaluate the efficacy of fallopian sperm perfusion (FSP) in comparison with standard intrauterine insemination (IUI) in natural cycle for couples with unexplained infertility or mild male factor.

Detailed Description

A number of randomised controlled trials have been published comparing the efficacy of FSP with standard IUI. A recent meta-analysis has suggested that in couples with unexplained infertility Fallopian tube sperm perfusion together with controlled ovarian hyperstimulation (COH) leads to increased pregnancy rates than IUI and COH. No study has been published comparing the two insemination techniques in natural cycle.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IUI	Active Comparator	Intrauterine insemination using standard catheter	Procedure: Intrauterine insemination using standard catheter
FSP	Experimental	Fallopian tube sperm perfusion using a commercial device for hysterosalpingography and tubal hydropertubation	Procedure: Fallopian tube sperm perfusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fallopian tube sperm perfusion	Procedure	Patients are treated with fallopian tube sperm perfusion	FSP

Measure	Description	Time Frame
clinical pregnancy rate		2 years

Measure	Description	Time Frame
Abortion rate		2 years
Ectopic pregnancy rate		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infertility for at least 2 years
age <40 years
unexplained infertility or mild male factor

Exclusion Criteria:

previous assisted reproduction treatment

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giuseppe Ricci, MD	IRCCS Burlo Garofolo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Burlo Garofolo		Trieste		34138	Italy