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

NCT ID: NCT00816387

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Insemination, Artificial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IUI

Intrauterine insemination using standard catheter

Group Type ACTIVE_COMPARATOR

Intrauterine insemination using standard catheter

Intervention Type PROCEDURE

Patients are treated with standard intrauterine insemination

FSP

Fallopian tube sperm perfusion using a commercial device for hysterosalpingography and tubal hydropertubation

Group Type EXPERIMENTAL

Fallopian tube sperm perfusion

Intervention Type PROCEDURE

Patients are treated with fallopian tube sperm perfusion

Interventions

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Fallopian tube sperm perfusion

Patients are treated with fallopian tube sperm perfusion

Intervention Type PROCEDURE

Intrauterine insemination using standard catheter

Patients are treated with standard intrauterine insemination

Intervention Type PROCEDURE

Other Intervention Names

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Cervical cup Balloon catheter

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* previous assisted reproduction treatment
Minimum Eligible Age

24 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Burlo Garofolo

OTHER

Sponsor Role lead

Responsible Party

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IRCCS Burlo Garofolo

Principal Investigators

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Giuseppe Ricci, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Burlo Garofolo

Locations

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IRCCS Burlo Garofolo

Trieste, , Italy

Site Status

Countries

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Italy

Other Identifiers

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RU01/07

Identifier Type: -

Identifier Source: org_study_id