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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00449449

Enrollment

330

Registered

2007-03-20

Start date

2003-09-30

Completion date

2006-09-30

Last updated

2007-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Pertubation, tubal flushing, intrauterine insemination.

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.

Interventions

DRUGPertubation with Lidocain Solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
clinical pregnancy	—

Secondary

Measure	Time frame
Pregnancy rate measured by Serum-HCG day 17 after IUI	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026