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A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

Unexplained Infertility Clinical Trial

Official title:
A Randomized, Double Blind, Controlled, Parallel Groups, Multi-center Phase II Clinical Study of Lidocaine Pertubation as a Treatment for Couples With Unexplained Infertility

Clinical Trial Summary

The present investigation is evaluating a method for improving pregnancy outcome of couples with unexplained infertility. The method utilizes an adjuvant pre-treatment prior to insemination, that is pertubation, i.e. flushing the uterus and fallopian tubes before insemination with a specially developed solution with the aim to increase fertility. The clinical trial is a phase II double blind, randomized, controlled and multi-center trial .

Clinical Trial Description

Couples interested in participating in the clinical study must have undergone a complete investigation for their infertility and have at least one year of unsuccessful attempts to achieve pregnancy. Following inclusion in the study, patients will be monitored with vaginal ultrasound to ensure a leading follicle of at least 18 mm.The subjects with one or two follicles ≥18 mm will be given Ovitrelle® (Merck), dose 250 ug (6500 IU) of Human Chorionic Gonadotropin (HCG), subcutaneously for ovulation induction. 12-24 h after the HCG injection, patients will be randomized and pertubated with either test or control solution.

12 -24 hours after the pertubation insemination (IUI) will be given to all patients. A blood sample is taken 14-17 days after IUI, for analysis of serum HCG level and possible pregnancy. In case of positive answer a second confirmatory sample will be obtained 48-72 hours later. In case of confirmed elevated HCG, the clinical pregnancy (CP) will be assessed with vaginal ultrasound examination 6-7 week after IUI. Baby take home rate data will be collected for couples with clinical pregnancy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03386552
Study type Interventional
Source Isifer AB
Contact Tomasz Rokicki, MD, PhD
Phone +48 500 900 888
Email t-rokicki@invimed.pl
Status Recruiting
Phase Phase 2
Start date June 20, 2017
Completion date March 31, 2019
View Details
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