Clinical trial NCT02315040: EVIE-Study: Slow Release Insemination Versus Standard Intrauterine Insemination Study
Official title: Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Insemination
Keywords: Intrauterine insemination (IUI)
Insemination method
Slow release insemination (SRI)
EVIE
Pregnancy rate
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Reproductive Sciences Ltd.
First posted: 2014-12-11
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy rate
timeFrame: average time frame: 2 weeks after insemination
Secondary outcomes:
Other outcomes:
Locations:
city: Dobl
country: Austria
facility: Das Kinderwunsch Institut Schenk GmbH
city: Vienna
country: Austria
facility: Dept. Obstetrics and Gynaecology, Medical University of Vienna
city: Vienna
country: Austria
facility: Kinderwunschzentrum der Goldenes Kreuz Privatklinik
city: Lyon
country: France
facility: CRES Hopital Natecia
city: Aachen
country: Germany
facility: Dept. Obstetrics and Gynaekology, Medical Faculty of Aachen
state: Westfalen
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang-Goethe-Universität Klinik für Frauenheilkunde und Geburtshilfe
city: Karlsruhe
country: Germany
facility: Frauenärztliche Gemeinschaftspraxis Dr. Maarten R. van Santen; KriegsstraBe 216
city: Munich
country: Germany
facility: LMU, Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
city: Munich
country: Germany
facility: Kinderwunsch Centrum München Pasing
city: Munich
country: Germany
facility: Kinderwunschzentrum München Bogenhausen
city: Withington
country: United Kingdom
facility: Fertility Fusion/Withington Hospital
state: Lancashire
city: London
country: United Kingdom
facility: Centre for Reproductive and Genetic Health - Eastman Dental Hospital
state: UK
Study officials:
affiliation: Medical University of Vienna
name: Maximilian B Franz, MD
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Christian Egarter, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Julian Marschalek, MD
role: STUDY_CHAIR
References:
citation: 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.