A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

Phase 2

• Conditions: Unexplained Infertility
• Interventions: Drug: Buffer; Drug: Isifera+

• Registration Number: NCT03386552
• Lead Sponsor: Isifer AB

Brief 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.

Study Timeline

• Study Start: 2017-06-20
• Status Verified: 2017-12
• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-28
• Last Update Submitted: 2017-12-28
• Study First Posted: 2017-12-29
• Last Update Posted: 2017-12-29
• Primary Completion: 2018-05-31
• Study Completion: 2019-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buffer	Buffer	Subjects are pertubated with a buffer solution without lidocaine
Isifera+	Isifera+	Subjects are pertubated with Isifer+ solution containing lidocaine 0.5 mg/ml

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	day 14-17 after IUI	serum-HCG

Secondary Outcome Measures

Name	Time	Method
Baby take home rate	At delivery / Miscarriage	Delivery of baby

Trial Locations

Locations (1)

InviMed-T sp. z o.o; 🇵🇱 Warszawa, Poland