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

Insemination, Artificial Clinical Trial

Official title:

Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle: a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816387
• Other study ID #: RU01/07
• Status: Completed
• Phase: N/A
• First received: December 31, 2008
• Last updated: December 2, 2010
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2009
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insemination, Artificial

Intervention

Procedure:
• Fallopian tube sperm perfusion
Patients are treated with fallopian tube sperm perfusion
• Intrauterine insemination using standard catheter
Patients are treated with standard intrauterine insemination

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate		2 years	No
Secondary	Abortion rate		2 years	No
Secondary	Ectopic pregnancy rate		2 years	Yes