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

Isifer

Status and phase

Completed

Phase 2

Conditions

Infertility

Treatments

Drug: Pertubation with Lidocain Solution

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00449449

ISI-03-1

Details and patient eligibility

About

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

Full 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.

Sex

Female

Ages

20 to 40 years old

Volunteers

No 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