NCT03386552

A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Isifer AB · Industry
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Not accepted

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 .

Detailed 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.

Conditions

• Unexplained Infertility

Interventions

Type	Name	Description
DRUG	Isifera+	Pertubation solution of lidocaine 0.5 mg ml in Ringer-Acetate buffer
DRUG	Buffer	Pertubation solution of Ringer-Acetate buffer

Timeline

• Start date: 2017-06-20
• Primary completion: 2018-05-31
• Completion: 2019-03-31
• First posted: 2017-12-29
• Last updated: 2017-12-29

Locations

1 site across 1 country: Poland