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

Not Applicable

Completed

• Conditions: Insemination, Artificial
• Interventions: Procedure: Intrauterine insemination using standard catheter; Procedure: Fallopian tube sperm perfusion

• Registration Number: NCT00816387
• Lead Sponsor: IRCCS Burlo Garofolo

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-12-31
• Study First Submitted QC: 2008-12-31
• Study First Posted: 2009-01-01
• Status Verified: 2009-03
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• previous assisted reproduction treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IUI	Intrauterine insemination using standard catheter	Intrauterine insemination using standard catheter
FSP	Fallopian tube sperm perfusion	Fallopian tube sperm perfusion using a commercial device for hysterosalpingography and tubal hydropertubation

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	2 years

Secondary Outcome Measures

Name	Time	Method
Abortion rate	2 years
Ectopic pregnancy rate	2 years

Trial Locations

Locations (1)

IRCCS Burlo Garofolo; 🇮🇹 Trieste, Italy