InfertilityPhase 2NCT00449449
A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
A Phase 2 study testing Pertubation with Lidocain Solution in people with Infertility, run by Isifer AB at 1 site in Sweden.
Trial summary
The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Pertubation with Lidocain Solution
- How many people
- 330 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2003to Sep 2006
- Phase
- Phase 2
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female,
- 20-40 years of age,
- If presence of peritoneal endometriosis they must be of minimal or mild without adhesions (verified by laparoscopy),
- Normal menstruation cycle,
- Male partner 20-70 years of age,
- Male partner,
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- Normal sperm sample within 5 years (>20x106/mL, total sperm count >30x106, normal morphology 5%),
- Duration of infertility more than one year,
- Signed informed consent
Who cannot join
- Treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection,
- Clinical signs of PID,
- Known hypersensitivity to local anesthetics,
- Non-patent fallopian tubes,
- Pathological uterine cavity,
- Pathological PCT, myoma > 2 cm diameter,
- Any disease or laboratory finding considered of importance by the investigator not to include the patient
Trial locations and contacts
1 site in 1 country.
Sweden1 site
1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge
Stockholm, Stockholm County, 141 86
About this study
Official title: A Randomised, Open, Controlled, Parallel Group, Multi-Centre Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.
Read the detailed description
In a prospective study, patients were randomized during a clomiphene citrate stimulated cycle to either pertubation with low-dose lidocain or no pertubation before insemination.
- Conditions
- Infertility
- Being tested
- Pertubation with Lidocain Solution
- Keywords
- Pertubation, tubal flushing, intrauterine insemination.
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pertubation with Lidocain SolutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy
Secondary outcomes (1)
Pregnancy rate measured by Serum-HCG day 17 after IUI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startSep 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants
Sponsor and investigators
- Lead sponsor
- Isifer AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Investigators
- Greta Edelstam, Md. PhD, Principal investigator, Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge, S-141 86 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449449
- Sponsor's protocol ID
- ISI-03-1
- Status last verified
- Mar 2007
- First submitted
- 17 Mar 2007
- Last updated
- 20 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Edelstam G, Sjosten A, Bjuresten K, Ek I, Wanggren K, Spira J. A new rapid and effective method for treatment of unexplained infertility. Hum Reprod. 2008 Apr;23(4):852-6. doi: 10.1093/humrep/den003. Epub 2008 Feb 15.
PubMed 18281242
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open, Controlled, Parallel Group, Multi-Centre Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT00449449
- Acronym / sponsor ID
- ISI-03-1
- Conditions
- Infertility
- Keywords
- Pertubation, tubal flushing, intrauterine insemination.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- Isifer ABIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Study start
- Sep 2003
- Study completion
- Sep 2006 (actual)
- First posted
- 20 Mar 2007 (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 study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.
Detailed description
In a prospective study, patients were randomized during a clomiphene citrate stimulated cycle to either pertubation with low-dose lidocain or no pertubation before insemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Female,
- 20-40 years of age,
- If presence of peritoneal endometriosis they must be of minimal or mild without adhesions (verified by laparoscopy),
- Normal menstruation cycle,
- Male partner 20-70 years of age,
Key exclusion criteria (7 listed)
- Treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection,
- Clinical signs of PID,
- Known hypersensitivity to local anesthetics,
- Non-patent fallopian tubes,
- Pathological uterine cavity,
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 |
|---|---|---|
| Pertubation with Lidocain Solution | Drug | – |
Primary outcome
clinical pregnancy
1 secondary outcome
Pregnancy rate measured by Serum-HCG day 17 after IUI
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 20 Mar 2007.
- Derived from this study: PubMed 18281242Edelstam G, Sjosten A, Bjuresten K, Ek I, Wanggren K, Spira J. A new rapid and effective method for treatment of unexplained infertility. Hum Reprod. 2008 Apr;23(4):852-6. doi: 10.1093/humrep/den003. Epub 2008 Feb 15.
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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.
Greta Edelstam, Md. PhD principal investigator
Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge, S-141 86 Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pertubation with Lidocain Solution in people with Infertility, run by Isifer AB at 1 site in Sweden.
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 9 inclusion and 7 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 20 Mar 2007. 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 Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00449449, which also lists 1 linked publication.
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 20 Mar 2007.