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Completed

NCT Number: NCT00449449

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

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge

Stockholm, Stockholm County, 141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pertubation with Lidocain Solution

Drug

Primary outcomes

  1. clinical pregnancy

Secondary outcomes

  1. Pregnancy rate measured by Serum-HCG day 17 after IUI

Sponsors and collaborators

Lead sponsor

Isifer AB

Industry

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Mar 20, 2007
Registry last updated
Mar 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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