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

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 .

Study Overview

• Status: Unknown
• Conditions: Unexplained Infertility
• Intervention / Treatment: Drug: Isifera+; Drug: Buffer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tomasz Rokicki, MD, PhD; Phone Number: +48 500 900 888; Email: t-rokicki@invimed.pl

Study Locations

• Poland
  • Warszawa, Poland, 02-532
    • Recruiting
    • InviMed-T sp. z o.o
    • Contact: Tomasz Rokicki, MD, PhD; Phone Number: +48 500 900 888; Email: t-rokicki@invimed.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Females with, unexplained infertility, 20-38 years of age. Normal menstrual cycle length of 26-35 days, male partner 20-70 years of age, Duration of infertility should have lasted more than one year and subject should have signed informed consent.

Couples must fulfil all laboratory tests for inclusion, negative HIV-1, HCV, HBV, CMV virology, chlamydia and syphilis. For female also negative toxoplasmosis, rubella and hormonal screen within normal range. Furthermore patent fallopian tubes should be confirmed by ultrasound hysterosalpingography and males should present a normal semen analysis

Exclusion Criteria:

Continuous treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection, clinical signs of PID, known hypersensitivity to local anaesthetics, non-patent fallopian tubes, abnormal uterine cavity, submucous myoma > 2 cm in diameter, any disease or laboratory finding considered of importance by the investigator not to include the patient, laparoscopically confirmed endometriosis of greater severity than mild, endometriosis of any severity with adhesions. More than 2 previous inseminations or previous unsuccessful IVF treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isifera+; Subjects are pertubated with Isifer+ solution containing lidocaine 0.5 mg/ml	Drug: Isifera+; Pertubation solution of lidocaine 0.5 mg ml in Ringer-Acetate buffer
Placebo Comparator: Buffer; Subjects are pertubated with a buffer solution without lidocaine	Drug: Buffer; Pertubation solution of Ringer-Acetate buffer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	serum-HCG	day 14-17 after IUI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baby take home rate	Delivery of baby	At delivery / Miscarriage

Collaborators and Investigators

• Sponsor: Isifer AB
• Collaborators: Ferring Pharmaceuticals; Vinnova
• Investigators: Study Chair: Jack Spira, Md PhD, Isifer AB

Publications and helpful links

General Publications

• Edelstam G, Sjosten A, Bjuresten K, Ek I, Wanggren K, Spira J. A new rapid and effective method for treatment of unexplained infertility. Hum Reprod. 2008 Apr;23(4):852-6. doi: 10.1093/humrep/den003. Epub 2008 Feb 15.

Helpful Links

• A new rapid and effective method for treatment of unexplained infertility.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Anticipated): May 31, 2018
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 28, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: ISI-2015-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No