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

Phase 3

• Conditions: Insemination
• Interventions: Other: Standard Intrauterine Insemination; Device: EVIE

• Registration Number: NCT02315040
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-10-19
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07
• Primary Completion: 2017-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IUI	Standard Intrauterine Insemination	standard intrauterine insemination method
EVIE	EVIE	Slow release insemination method (SRI)

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	average time frame: 2 weeks after insemination	ß-HCG examination in urine or serum

Trial Locations

Locations (12)

Dept. Obstetrics and Gynaekology, Medical Faculty of Aachen; 🇩🇪 Aachen, Westfalen, Germany

CRES Hopital Natecia; 🇫🇷 Lyon, France

LMU, Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe; 🇩🇪 Munich, Germany

Centre for Reproductive and Genetic Health - Eastman Dental Hospital; 🇬🇧 London, UK, United Kingdom

Klinikum der Johann Wolfgang-Goethe-Universität Klinik für Frauenheilkunde und Geburtshilfe; 🇩🇪 Frankfurt am Main, Germany

Kinderwunsch Centrum München Pasing; 🇩🇪 Munich, Germany

Kinderwunschzentrum München Bogenhausen; 🇩🇪 Munich, Germany

Das Kinderwunsch Institut Schenk GmbH; 🇦🇹 Dobl, Austria

Frauenärztliche Gemeinschaftspraxis Dr. Maarten R. van Santen; KriegsstraBe 216; 🇩🇪 Karlsruhe, Germany

Fertility Fusion/Withington Hospital; 🇬🇧 Withington, Lancashire, United Kingdom

Dept. Obstetrics and Gynaecology, Medical University of Vienna; 🇦🇹 Vienna, Austria

Kinderwunschzentrum der Goldenes Kreuz Privatklinik; 🇦🇹 Vienna, Austria