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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isifer AB
• Collaborator: Karolinska Institutet
• Treatments: Lidocaine

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