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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

Page last updated: August 23, 2015

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