Insemination
Conditions
Keywords
Intrauterine insemination (IUI), Insemination method, Slow release insemination (SRI), EVIE, Pregnancy rate
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.
Interventions
DEVICEEVIE
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
OTHERStandard Intrauterine Insemination
standard intrauterine insemination procedure
Sponsors
Reproductive Sciences Ltd.
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | average time frame: 2 weeks after insemination | ß-HCG examination in urine or serum |
Countries
Austria, France, Germany, United Kingdom
Contacts
Primary ContactJulian Marschalek, MD
Backup ContactMaximilian B Franz, MD
Outcome results
None listed