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

March 19, 2007 updated by: Isifer AB

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

330

Phase

  • Phase 2

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

  • Sweden
      • Stockholm, Sweden, 141 86
        • 1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
clinical pregnancy

Secondary Outcome Measures

Outcome Measure
Pregnancy rate measured by Serum-HCG day 17 after IUI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isifer AB

Collaborators

Karolinska Institutet

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2003

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

March 17, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Estimate)

March 20, 2007

Last Update Submitted That Met QC Criteria

March 19, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISI-03-1

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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