A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

Isifer AB120 enrolled

Overview

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 .

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Unexplained Infertility

Interventions

Isifera+DRUG

Pertubation solution of lidocaine 0.5 mg ml in Ringer-Acetate buffer

BufferDRUG

Pertubation solution of Ringer-Acetate buffer

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 38 Years

Medical Language ↔ Plain English

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.

Locations (1)

InviMed-T sp. z o.o

Warsaw, Poland

RECRUITING

Outcomes

Primary Outcomes

Pregnancy rate

serum-HCG

Time frame: day 14-17 after IUI

Secondary Outcomes

Baby take home rate

Delivery of baby

Time frame: At delivery / Miscarriage

Central Contacts

Tomasz Rokicki, MD, PhD

CONTACT

+48 500 900 888 t-rokicki@invimed.pl

Data from ClinicalTrials.gov

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