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

Study Overview
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Brief Summary
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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.

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

Conditions
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Insemination

Intervention / Treatment
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* Device: EVIE
* Other: Standard Intrauterine Insemination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with primary or secondary infertility after 6 months of unprotected intercourse who are candidates for IUI Age of the woman - 20 to 40 years old Normal uterus x-ray (HSG) or Chromotubation to determine tubal patency Women with infertility on a background of non-ovulation Infertility on a background of a male problem (over 10 million/ml motile sperm cells per sample) Infertility on a background of unexplained cause Same sex patient / single patient Signed informed consent Exclusion Criteria: Woman under the age of 20 or over the age of 40 years Female infertility on mechanical background affecting the uterus or Fallopian tubes Infertility on male background of medium to very low level of spermatozoa - less than 10 million/ml motile sperm cells per sample Men and women who are opposed to the random spermatozoa insemination method Participants who are not willing to sign the Consent Form BMI >30

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IUI<br>standard intrauterine insemination method | Other: Standard Intrauterine Insemination<br>* standard intrauterine insemination procedure<br>* Other names: IUI;|
| Experimental: EVIE<br>Slow release insemination method (SRI) | Device: EVIE<br>* 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<br>* Other names: Slow Release Insemination (SRI);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine insemination (IUI), Insemination method, Slow release insemination (SRI), EVIE, Pregnancy rate