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

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ClinicalTrials.gov Identifier: NCT00816387
Recruitment Status : Completed
First Posted : January 1, 2009
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Insemination, Artificial Procedure: Fallopian tube sperm perfusion Procedure: Intrauterine insemination using standard catheter

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle: a Prospective Randomized Study
Study Start Date : October 2007
Primary Completion Date : October 2009
Study Completion Date : December 2009
Arms and Interventions

Arm Intervention/treatment
Active Comparator: IUI
Intrauterine insemination using standard catheter
Procedure: Intrauterine insemination using standard catheter
Patients are treated with standard intrauterine insemination
Other Name: Balloon catheter
Experimental: FSP
Fallopian tube sperm perfusion using a commercial device for hysterosalpingography and tubal hydropertubation
Procedure: Fallopian tube sperm perfusion
Patients are treated with fallopian tube sperm perfusion
Other Name: Cervical cup


Outcome Measures

Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Abortion rate [ Time Frame: 2 years ]
  2. Ectopic pregnancy rate [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • previous assisted reproduction treatment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816387


Locations
Italy
IRCCS Burlo Garofolo
Trieste, Italy, 34138
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
Principal Investigator: Giuseppe Ricci, MD IRCCS Burlo Garofolo
More Information

Responsible Party: Giuseppe Ricci, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00816387     History of Changes
Other Study ID Numbers: RU01/07
First Posted: January 1, 2009    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: March 2009