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

IRCCS Burlo Garofolo

Status: Completed

Conditions: Insemination, Artificial

Treatments: Procedure: Intrauterine insemination using standard catheter; Procedure: Fallopian tube sperm perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00816387

RU01/07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 24 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• previous assisted reproduction treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

IUI

Active Comparator group

Description:

Intrauterine insemination using standard catheter

Treatment:

Procedure: Intrauterine insemination using standard catheter

FSP

Experimental group

Description:

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

Treatment:

Procedure: Fallopian tube sperm perfusion