A Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen.
- Registration Number
- NCT02809989
- Lead Sponsor
- Teva Pharma GmbH
- Brief Summary
The aim of this non-interventional study is to extend the knowledge on effectiveness of Ovaleap® (number of oocytes and pregnancy rate) during routine IVF- or ICSI-treatment using a Gonadotropin-releasing hormone (GnRH) antagonist protocol in a large number of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 507
-
Women with a medical indication for an ovarian stimulation therapy for the purposes of an IVF or ICSI.
-
First-time ovarian stimulating therapy for an IVF or ICSI.
-
Ovarian stimulation therapy exclusively with Ovaleap®.
-
GnRH antagonist protocol.
-
Body-Mass-Index (BMI) < 30 kg/m2.
-
Duration of menstrual cycle 24 - 35 days.
- Additional criteria apply, please contact the investigator for more information
- Combined application of IVF and ICSI
- Ovarian hyperstimulation with Ovaleap® with a consecutive "social freezing".
- Polycystic ovary syndrome (PCOS).
- Endometriosis (AFS (American Fertility Society) grade 3 and 4).
- Uterine myoma (intramural > 4 cm, submucosal).
- Hydrosalpinx (on one side or both sides).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ovaleap® Ovaleap® Single group prospective treatment cohort
- Primary Outcome Measures
Name Time Method Clinical pregnancy rate 12 months Number of retrieved oocytes after ovarian stimulation therapy 12 months
- Secondary Outcome Measures
Name Time Method Number of days with administration of Ovaleap® 12 months Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation 12 months Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist) 12 months Number of Metaphase II (MII)-oocytes 12 months Percentage fertilisation rate 12 months * IVF: number of fertilised oocytes in 2-pro nucleus (2-PN)-stage / number of inseminated MII-oocytes as a percentage.
* ICSI: number of fertilised oocytes in 2-PN-stage / number of injected MII-oocytes as a percentage.Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos 12 months Luteal phase support (LPS): product, dose and duration of administration 12 months Frequency and intensity of adverse drug reactions (ADRs) 12 months Rate of multiple pregnancies (twins, triplets, quadruplets). 12 months Level of serum estradiol at the time of the last examination prior to induction of ovulation 12 months "Baby-Take-Home-Rate" (live-births). 12 months Administered total dose of Ovaleap® 12 months User satisfaction with the Ovaleap®-pen 12 months Patient Questionnaire completed by patient
Trial Locations
- Locations (37)
Teva Investigational Site 017
🇩🇪Berlin, Germany
Teva Investigational Site 006
🇩🇪München, Germany
Teva Investigational Site 034
🇩🇪Aalen, Baden-Württemberg, Germany
Teva Investigational Site 032
🇩🇪Regensburg, Bayern, Germany
Teva Investigational Site 003
🇩🇪Düsseldorf, Germany
Teva Investigational Site 014
🇩🇪Ludwigsburg, Germany
Teva Investigational Site 018
🇩🇪Münster, Germany
Teva Investigational Site 024
🇩🇪Ulm, Germany
Teva Investigational Site 026
🇩🇪Munchen, Bayern, Germany
Teva Investigational Site 033
🇩🇪Kempten, Bayern, Germany
Teva Investigational Site 004
🇩🇪Berlin, Germany
Teva Investigational Site 035
🇩🇪Ludwigshafen, Rheinland-Pfalz, Germany
Teva Investigational Site 015
🇩🇪Berlin, Germany
Teva Investigational Site 036
🇩🇪Aalen, Germany
Teva Investigational Site 031
🇩🇪Berlin, Germany
Teva Investigational Site 022
🇩🇪Bielefeld, Germany
Teva Investigational Site 027
🇩🇪Berlin, Germany
Teva Investigational Site 013
🇩🇪Dortmund, Germany
Teva Investigational Site 021
🇩🇪Kiel, Germany
Teva Investigational Site 029
🇩🇪Leipzig, Germany
Teva Investigational Site 030
🇩🇪München, Germany
Teva Investigational Site 010
🇩🇪Düsseldorf, Germany
Teva Investigational Site 025
🇩🇪Esslingen, Germany
Teva Investigational Site 012
🇩🇪Großhansdorf, Germany
Teva Investigational Site 011
🇩🇪Essen, Germany
Teva Investigational Site 016
🇩🇪Hannover, Germany
Teva Investigational Site 023
🇩🇪Magdeburg, Germany
Teva Investigational Site 005
🇩🇪Ulm, Germany
Teva Investigational Site 028
🇩🇪Hildesheim, Germany
Teva Investigational Site 020
🇩🇪Lübeck, Germany
Teva Investigational Site 037
🇩🇪Hamburg, Germany
Teva Investigational Site 001
🇩🇪Wiesbaden, Germany
Teva Investigational Site 009
🇩🇪Osnabrück, Germany
Teva Investigational Site 007
🇩🇪Regensburg, Germany
Teva Investigational Site 002
🇩🇪Rostock, Germany
Teva Investigational Site 008
🇩🇪Saarbrücken, Germany
Teva Investigational Site 019
🇩🇪Stuttgart, Germany