- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00816387
Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle
December 2, 2010 updated by: IRCCS Burlo Garofolo
Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle: a Prospective Randomized Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Trieste, Italy, 34138
- IRCCS Burlo Garofolo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
24 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- infertility for at least 2 years
- age <40 years
- unexplained infertility or mild male factor
Exclusion Criteria:
- previous assisted reproduction treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: IUI
Intrauterine insemination using standard catheter
|
Patients are treated with standard intrauterine insemination
Other Names:
|
EXPERIMENTAL: FSP
Fallopian tube sperm perfusion using a commercial device for hysterosalpingography and tubal hydropertubation
|
Patients are treated with fallopian tube sperm perfusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical pregnancy rate
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ectopic pregnancy rate
Time Frame: 2 years
|
2 years
|
Abortion rate
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (ACTUAL)
October 1, 2009
Study Completion (ACTUAL)
December 1, 2009
Study Registration Dates
First Submitted
December 31, 2008
First Submitted That Met QC Criteria
December 31, 2008
First Posted (ESTIMATE)
January 1, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 3, 2010
Last Update Submitted That Met QC Criteria
December 2, 2010
Last Verified
March 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- RU01/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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