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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03386552
• Other study ID #: ISI-2015-1
• Status: Recruiting
• Phase: Phase 2
• First received: December 21, 2017
• Last updated: December 28, 2017
• Start date: June 20, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: December 2017
• Source: Isifer AB
• Contact: Tomasz Rokicki, MD, PhD
• Phone: +48 500 900 888
• Email: t-rokicki[@]invimed.pl
• Is FDA regulated: No
• Study type: Interventional

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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2019
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Unexplained Infertility

Intervention

Drug:
• Isifera+
Pertubation solution of lidocaine 0.5 mg ml in Ringer-Acetate buffer
• Buffer
Pertubation solution of Ringer-Acetate buffer

Locations

Country	Name	City	State
Poland	InviMed-T sp. z o.o	Warszawa

Sponsors (3)

Lead Sponsor	Collaborator
Isifer AB	Ferring Pharmaceuticals, Vinnova

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Edelstam G, Sjösten A, Bjuresten K, Ek I, Wånggren 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	serum-HCG	day 14-17 after IUI
Secondary	Baby take home rate	Delivery of baby	At delivery / Miscarriage

External Links

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