Intrauterine instillation of diluted seminal plasma in in vitro fertilization a double-blind, placebo controlled, randomized study

Transkript

1 PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title Intrauterine instillation of diluted seminal plasma in in vitro fertilization a double-blind, placebo controlled, randomized study Trial Acronym [---]* URL of the trial [---]* Brief Summary in Lay Language At the time of oocyte aspiration in In vitro Fertilization (IVF) therapies, diluted seminal plasma of the patients partner or placebo (sodium chloride) is injected into the cervix. Thereby sexual intercourse is imitated, which does not take place in IVF therapies. The goal is to increase the pregnancy rate. Brief Summary in Scientific Language At the time of oocyte aspiration in In vitro Fertilization (IVF) therapies, diluted seminal plasma of the patients partner or placebo (sodium chloride) is injected into the cervix ti imitate sexual intercourse is imitated. The therapy is aimed to increase the pregnancy rate. Organizational Data DRKS-ID: DRKS Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: S-061/2003, Ethik-Kommission I der Medizinischen Fakultät Heidelberg Secondary IDs Page 1 of 5

2 Health condition or Problem studied ICD10: N Female infertility associated with anovulation Interventions/Observational Groups Arm 1: Injection of seminal plasma into the cervix Arm 2: Injection of sodium chloride into the cervix Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: Double or multiple blind Who is blinded: patient/subject, therapist/clinician Control: Placebo Purpose: Treatment Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]* Primary Outcome Clinical pregnancy, at least amniotic sac. Thereby earliest ultrasound at 6+0 weeks of pregnancy / Secondary Outcome Countries of recruitment DE Germany Locations of Recruitment Page 2 of 5

3 University Medical Center Abteilung Gynäkologische Endokrinologie und Fertilitätsstörungen, Universitätsfrauenklinik, Heidelberg Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2007/04/01 Target Sample Size: 422 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Female Minimum Age: 18 Years Maximum Age: 43 Years Additional Inclusion Criteria infertility, IVF therapy Exclusion criteria male urogenital infection Addresses Primary Sponsor Abteilung Gynäkologische Endokrinologie und Fertilitätsstörungen, Mr. Prof. Dr. Thomas Strowitzki Vossstrasse Heidelberg Germany Telephone: thomas.strowitzki at med.uni-heidelberg.de Contact for Scientific Queries Abteilung Gynäkologische Endokrinologie und Reproduktionsmedizin, Page 3 of 5

4 Contact for Scientific Queries Abteilung Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse Bern Switzerland Telephone: Michael.vonWolff at insel.ch Contact for Public Queries Abteilung Gynäkologische Endokrinologie und Reproduktiosnmedizin, Effingerstrasse Bern Switzerland Telephone: Michael.vonWolff at insel.ch Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Abteilung Gynäkologische Endokrinologie und Fertilitätsstörungen, Mr. Prof. Dr. Thomas Strowitzki Vossstrasse Heidelberg Germany Telephone: thomas.strowitzki at med.uni-heidelberg.de Status Recruitment Status: Recruiting stopped after recruiting started Study Closing (LPLV): 2012/02/28 Page 4 of 5

5 Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 5 of 5