Insemination, ArtificialNCT00816387
Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle
A study testing Fallopian tube sperm perfusion and Intrauterine insemination using standard catheter in people with Insemination, Artificial, run by IRCCS Burlo Garofolo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 24 to 40 years, women only
- Conditions the study is for
- Insemination, Artificial
- What is being tested?
- Fallopian tube sperm perfusion and Intrauterine insemination using standard catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertility for at least 2 years
- age <40 years
- unexplained infertility or mild male factor
Who cannot join
- previous assisted reproduction treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Insemination, Artificial
- Being tested
- Fallopian tube sperm perfusion, Intrauterine insemination using standard catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fallopian tube sperm perfusionProcedure or surgery
Also called Cervical cup
Patients are treated with fallopian tube sperm perfusion
Intrauterine insemination using standard catheterProcedure or surgery
Also called Balloon catheter
Patients are treated with standard intrauterine insemination
| Study group | Role | What they receive |
|---|---|---|
| IUI | Active comparator | Intrauterine insemination using standard catheter Receives: Procedure: Intrauterine insemination using standard catheter |
| FSP | Experimental | Fallopian tube sperm perfusion using a commercial device for hysterosalpingography and tubal hydropertubation Receives: Procedure: Fallopian tube sperm perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Measured: 2 years
Secondary outcomes (2)
Abortion rate
Measured: 2 years
Ectopic pregnancy rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insemination, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Ricci, MD, Principal investigator, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816387
- Sponsor's protocol ID
- RU01/07
- Status last verified
- Mar 2009
- First submitted
- 31 Dec 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00816387
- Acronym / sponsor ID
- RU01/07
- Conditions
- Insemination, Artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IUI | Active comparator | Procedure: Intrauterine insemination using standard catheterIntrauterine insemination using standard catheter |
| FSP | Experimental | Procedure: Fallopian tube sperm perfusionFallopian tube sperm perfusion using a commercial device for hysterosalpingography and tubal hydropertubation |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- infertility for at least 2 years
- age <40 years
- unexplained infertility or mild male factor
Key exclusion criteria (1 listed)
- previous assisted reproduction treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fallopian tube sperm perfusionAlso: Cervical cupPatients are treated with fallopian tube sperm perfusion | Procedure or surgery | FSP |
| Intrauterine insemination using standard catheterAlso: Balloon catheterPatients are treated with standard intrauterine insemination | Procedure or surgery | IUI |
Primary outcome
clinical pregnancy rate
Time frame: 2 years
2 secondary outcomes
Abortion rate
Time frame: 2 years
Ectopic pregnancy rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Ricci, MD principal investigator
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fallopian tube sperm perfusion and Intrauterine insemination using standard catheter in people with Insemination, Artificial, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2010.