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

This study has been completed.
Sponsor:
Information provided by:
IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT00816387
First received: December 31, 2008
Last updated: December 2, 2010
Last verified: March 2009
  Purpose

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 Intervention
Insemination, Artificial
Procedure: Fallopian tube sperm perfusion
Procedure: Intrauterine insemination using standard catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle: a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Abortion rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Ectopic pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   24 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Giuseppe Ricci, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00816387     History of Changes
Other Study ID Numbers: RU01/07
Study First Received: December 31, 2008
Last Updated: December 2, 2010
Health Authority: Italy: Ministry of Health

ClinicalTrials.gov processed this record on August 28, 2014