Trial | NCT00449449  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lidocaine ...

  • Study Participants

    330
The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.
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 Started
Sep 30
2003
Study Completion
Sep 30
2006
Last Update
Mar 20
2007
Estimate

Drug Pertubation with Lidocain Solution

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
No Results Posted