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

Infertility Clinical Trial

Official title:

A Randomised, Open, Controlled, Parallel Group, Multi-Centre Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449449
• Other study ID #: ISI-03-1
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2007
• Last updated: March 19, 2007
• Start date: September 2003
• Est. completion date: September 2006

Study information

• Verified date: March 2007
• Source: Isifer AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Pertubation with Lidocain Solution

Locations

Country	Name	City	State
Sweden	1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Isifer AB	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy
Secondary	Pregnancy rate measured by Serum-HCG day 17 after IUI