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.
NCT ID: NCT02809989
Last Updated: 2021-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
507 participants
OBSERVATIONAL
2016-03-31
2018-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ovaleap®
Single group prospective treatment cohort
Ovaleap®
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).
Interventions
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Ovaleap®
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).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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).
18 Years
40 Years
FEMALE
No
Sponsors
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Teva Pharma GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 034
Aalen, Baden-Wurttemberg, Germany
Teva Investigational Site 033
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
Countries
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References
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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.
Other Identifiers
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XM17-WH-40103
Identifier Type: -
Identifier Source: org_study_id