EVIE-Study: Slow Release Insemination Versus Standard Intrauterine Insemination Study
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insemination
Intervention: EVIE (Device); Standard Intrauterine Insemination (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s): Maximilian B Franz, MD, Study Chair, Affiliation: Medical University of Vienna Christian Egarter, MD, Prof., Principal Investigator, Affiliation: Medical University of Vienna Julian Marschalek, MD, Study Chair, Affiliation: Medical University of Vienna
Overall contact: Julian Marschalek, MD, Phone: +4314040028160, Email: julian.marschalek@meduniwien.ac.at
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 250 patients.
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.
Secondary endpoints:
• An ultrasound viability scan will be carried out four-five weeks after insemination.
Clinical Details
Official title: Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pregnancy rate
Secondary outcome: Ultrasound visibility of pregnancy
Eligibility
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Julian Marschalek, MD, Phone: +4314040028160, Email: julian.marschalek@meduniwien.ac.at
Das Kinderwunsch Institut Schenk GmbH, Dobl 8143, Austria; Recruiting Michael Schenk, MD, Phone: +43 699 155 11133, Email: m.schenk@kinderwunsch-institut.at
Dept. Obstetrics and Gynaecology, Medical University of Vienna, Vienna 1090, Austria; Recruiting Julian Marschalek, MD, Phone: 0043140400291600, Email: julian.marschalek@meduniwien.ac.at Julian Marschalek, MD, Sub-Investigator Christian Egarter, MD, Prof., Principal Investigator
Kinderwunschzentrum der Goldenes Kreuz Privatklinik, Vienna 1090, Austria; Active, not recruiting
CRES Hopital Natecia, Lyon 69008, France; Recruiting Antoine Watrelot, MD, Prof., Phone: 00 33 609 423387, Email: watrelot@wanadoo.fr
Klinikum der Johann Wolfgang-Goethe-Universität Klinik für Frauenheilkunde und Geburtshilfe, Frankfurt am Main 60590, Germany; Active, not recruiting
Frauenärztliche Gemeinschaftspraxis Dr. Maarten R. van Santen; KriegsstraBe 216, Karlsruhe 76135, Germany; Recruiting Maarten van Santen, MD, Phone: +49-721-684396, Email: Info@dr-vanSanten.de
Kinderwunsch Centrum München Pasing, Munich 81241, Germany; Recruiting Jan Krüsmann, MD, Phone: +49 89 244 1440, Email: Jan.kruesmann@gmail.de
Kinderwunschzentrum München Bogenhausen, Munich 81675, Germany; Active, not recruiting
LMU, Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Munich 80337, Germany; Active, not recruiting
Centre for Reproductive and Genetic Health - Eastman Dental Hospital, London, UK WC1X8LD, United Kingdom; Recruiting Wael Saab, MD, Phone: +44 207 837 2905, Email: wael.saab@crgh.co.uk
Dept. Obstetrics and Gynaekology, Medical Faculty of Aachen, Aachen, Westfalen 52074, Germany; Active, not recruiting
Additional Information
Related 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.
Starting date: March 2012
Last updated: December 9, 2014
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