A Phase II Clinical Study of Lidocain Pertubation as Trea... | NCT00449449

Studies
A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility

NCT00449449

Sponsor

Isifer AB

Status

Completed

Last Update Posted

Mar 20, 2007Estimated

Enrollment

330

Phase

Phase 2

Conditions

Infertility

Interventions

Pertubation with Lidocain Solution

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Sep 2006Actual

First Submitted Date

Mar 17, 2007

First Submission Date that Met QC Criteria

Mar 19, 2007

First Posted Date

Mar 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2007

Last Update Posted Date

Mar 20, 2007Estimated

Name	Class
Karolinska Institutet	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

330

Name	Type	Description	Arm Group Labels	Other Names
Pertubation with Lidocain Solution	Drug

Measure	Description	Time Frame
clinical pregnancy

Measure	Description	Time Frame
Pregnancy rate measured by Serum-HCG day 17 after IUI

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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,
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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Greta Edelstam, Md. PhD	Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge, S-141 86 Stockholm, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge		Stockholm	Stockholm County	141 86	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18281242	Derived	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases