EVIE-Study: Slow Release Insemination Versus Standard Intrauterine Insemination Study (EVIE)

Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)

Overall Study Design and Plan Description

• The study will be conducted on women with fertility difficulties who are designated for intrauterine insemination treatment (IUI). The research sample size is 137 treatment cycles per group (total of 274 treatment cycles). The women will be randomly divided into two groups. Some will undergo the standard bolus IUI treatment and others will be treated with the EVIE Slow Release Insemination method (SRI). Women who fail to conceive in the first treatment will next receive the alternative treatment. This means that a woman treated with the IUI method who does not become pregnant will then be treated with SRI, and vice versa (crossover method). The study will include women treated with Clomiphene Citrate or with other Gonadotropin-based treatment. Every couple treated will undergo at least 2 insemination cycles (unless pregnancy has already been achieved).
• Before beginning the hormone treatment, each couple will have the trial procedure explained to them. This explanation will include all the detailed information and instruction about the IUI and the Slow Release Insemination methods. A Patient Information Sheet will be available to them.
• Preparation of the spermatozoa for intra uterine insemination will be identical to the method performed currently before IUI.

Approximately two weeks after the insemination treatment, a blood sample will be taken from the woman to check for Beta hCG levels to indicate pregnancy.

Hypothesis:

SRI leads to higher pregnancy rates compared to standard IUI

Primary endpoint:

• Pregnancy rate Effect of controlled Intra-uterine slow release insemination on the pregnancy rate of women designated for intra uterine insemination in comparison to the accepted IUI method.

Study Overview

• Status: Unknown
• Conditions: Insemination
• Intervention / Treatment: Other: Standard Intrauterine Insemination; Device: EVIE

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Dobl, Austria, 8143
    • Completed
    • Das Kinderwunsch Institut Schenk GmbH
  • Vienna, Austria, 1090
    • Active, not recruiting
    • Dept. Obstetrics and Gynaecology, Medical University of Vienna
  • Vienna, Austria, 1090
    • Active, not recruiting
    • Kinderwunschzentrum der Goldenes Kreuz Privatklinik
• France
  • Lyon, France, 69008
    • Completed
    • CRES Hopital Natecia
• Germany
  • Frankfurt am Main, Germany, 60590
    • Active, not recruiting
    • Klinikum der Johann Wolfgang-Goethe-Universität Klinik für Frauenheilkunde und Geburtshilfe
  • Karlsruhe, Germany, 76135
    • Completed
    • Frauenärztliche Gemeinschaftspraxis Dr. Maarten R. van Santen; KriegsstraBe 216
  • Munich, Germany, 80337
    • Active, not recruiting
    • LMU, Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
  • Munich, Germany, 81241
    • Completed
    • Kinderwunsch Centrum München Pasing
  • Munich, Germany, 81675
    • Active, not recruiting
    • Kinderwunschzentrum München Bogenhausen
  • Westfalen
    • Aachen, Westfalen, Germany, 52074
      • Active, not recruiting
      • Dept. Obstetrics and Gynaekology, Medical Faculty of Aachen
• United Kingdom
  • Lancashire
    • Withington, Lancashire, United Kingdom, WN6 9EP
      • Recruiting
      • Fertility Fusion/Withington Hospital
      • Contact: C Philip Harris, MD; Phone Number: +44 (0) 1257 256251; Email: info@fertilityfusion.co.uk
  • UK
    • London, UK, United Kingdom, WC1X8LD
      • Recruiting
      • Centre for Reproductive and Genetic Health - Eastman Dental Hospital
      • Contact: Wael Saab, MD; Phone Number: +44 207 837 2905; Email: wael.saab@crgh.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women with primary or secondary infertility after 6 months of unprotected intercourse who are candidates for IUI
2. Age of the woman - 20 to 40 years old
3. Normal uterus x-ray (HSG) or Chromotubation to determine tubal patency
4. Women with infertility on a background of non-ovulation
5. Infertility on a background of a male problem (over 10 million/ml motile sperm cells per sample)
6. Infertility on a background of unexplained cause
7. Same sex patient / single patient
8. Signed informed consent

Exclusion Criteria:

1. Woman under the age of 20 or over the age of 40 years
2. Female infertility on mechanical background affecting the uterus or Fallopian tubes
3. Infertility on male background of medium to very low level of spermatozoa - less than 10 million/ml motile sperm cells per sample
4. Men and women who are opposed to the random spermatozoa insemination method
5. Participants who are not willing to sign the Consent Form
6. BMI >30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IUI; standard intrauterine insemination method	Other: Standard Intrauterine Insemination; standard intrauterine insemination procedure; Other Names: IUI
Experimental: EVIE; Slow release insemination method (SRI)	Device: EVIE; EVIE is a small, mechanical, single use pump that mimics natural fertilization by introducing sperm into the uterus over a period of 4 hours, rather than all at once as in conventional IUI; Other Names: Slow Release Insemination (SRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	ß-HCG examination in urine or serum	average time frame: 2 weeks after insemination

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Reproductive Sciences Ltd.
• Investigators: Study Chair: Maximilian B Franz, MD, Medical University of Vienna; Principal Investigator: Christian Egarter, MD, Prof., Medical University of Vienna; Study Chair: Julian Marschalek, MD, Medical University of Vienna

Publications and helpful links

General Publications

• Muharib NS, Abdel Gadir A, Shaw RW. Slow release intrauterine insemination versus the bolus technique in the treatment of women with cervical mucus hostility. Hum Reprod. 1992 Feb;7(2):227-9. doi: 10.1093/oxfordjournals.humrep.a137622.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: October 19, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Pregnancy rate; Intrauterine insemination (IUI); Insemination method; Slow release insemination (SRI); EVIE
• Other Study ID Numbers: v1.2