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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovaleap® | Single group prospective treatment cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ovaleap® | Drug | About 6-8 weeks of observation per patient from start of the stimulation therapy with Ovaleap® depending on the duration of the required stimulating therapy. Up to 10-11 months per patient for follow-up but only if in case of songraphically intact intrauterine pregnancy to determinate the "Baby-Take-Home-Rate" (live-births). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of retrieved oocytes after ovarian stimulation therapy | 12 months | |
| Clinical pregnancy rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days with administration of Ovaleap® | 12 months | |
| Administered total dose of Ovaleap® | 12 months | |
| Level of serum estradiol at the time of the last examination prior to induction of ovulation |
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Inclusion Criteria:
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.
Exclusion Criteria:
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Patients who get an ovarian stimulation therapy with Ovaleap® as preparation for a technique of an assisted reproduction (here: In-vitro-Fertilisation (IVF) or Intracytoplasmatic Sperm Injection (ICSI).
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 034 | Aalen | Baden-Wurttemberg | Germany | |||
| Teva Investigational Site 033 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32456636 | Derived | Sydow P, Gmeinwieser N, Pribbernow K, Keck C, Wiegratz I. Effectiveness and safety of follitropin alfa (Ovaleap(R)) for ovarian stimulation using a GnRH antagonist protocol in real-world clinical practice: a multicenter, prospective, open, non-interventional assisted reproductive technology study. Reprod Biol Endocrinol. 2020 May 26;18(1):54. doi: 10.1186/s12958-020-00610-2. |
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|
| 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 |
| 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 |
| User satisfaction with the Ovaleap®-pen | Patient Questionnaire completed by patient | 12 months |
| "Baby-Take-Home-Rate" (live-births). | 12 months |
| Rate of multiple pregnancies (twins, triplets, quadruplets). | 12 months |
| Frequency and intensity of adverse drug reactions (ADRs) | 12 months |
| Kempten (Allgäu) |
| Bavaria |
| Germany |
| Teva Investigational Site 026 | München | Bavaria | Germany |
| Teva Investigational Site 032 | Regensburg | Bavaria | Germany |
| Teva Investigational Site 035 | Ludwigshafen am Rhein | Rhineland-Palatinate | Germany |
| Teva Investigational Site 036 | Aalen | Germany |
| Teva Investigational Site 004 | Berlin | Germany |
| Teva Investigational Site 015 | Berlin | Germany |
| Teva Investigational Site 017 | Berlin | Germany |
| Teva Investigational Site 027 | Berlin | Germany |
| Teva Investigational Site 031 | Berlin | Germany |
| Teva Investigational Site 022 | Bielefeld | Germany |
| Teva Investigational Site 013 | Dortmund | Germany |
| Teva Investigational Site 003 | Düsseldorf | Germany |
| Teva Investigational Site 010 | Düsseldorf | Germany |
| Teva Investigational Site 011 | Essen | Germany |
| Teva Investigational Site 025 | Esslingen am Neckar | Germany |
| Teva Investigational Site 012 | Großhansdorf | Germany |
| Teva Investigational Site 037 | Hamburg | Germany |
| Teva Investigational Site 016 | Hanover | Germany |
| Teva Investigational Site 028 | Hildesheim | Germany |
| Teva Investigational Site 021 | Kiel | Germany |
| Teva Investigational Site 029 | Leipzig | Germany |
| Teva Investigational Site 014 | Ludwigsburg | Germany |
| Teva Investigational Site 020 | Lübeck | Germany |
| Teva Investigational Site 023 | Magdeburg | Germany |
| Teva Investigational Site 006 | München | Germany |
| Teva Investigational Site 030 | München | Germany |
| Teva Investigational Site 018 | Münster | 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 |
| Teva Investigational Site 005 | Ulm | Germany |
| Teva Investigational Site 024 | Ulm | Germany |
| Teva Investigational Site 001 | Wiesbaden | Germany |