Clinical trial NCT02809989: 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.
Official title: Multicentre, Prospective, Open, Non-interventional Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen in the Clinical Routine of the IVF- / ICSI-treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Rate
Oocytes
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-22
Enrollment: 507
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.


Eligibility criteria: 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.

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Number of retrieved oocytes after ovarian stimulation therapy
timeFrame: 12 months
measure: Clinical pregnancy rate
timeFrame: 12 months
Secondary outcomes:
measure: Number of days with administration of Ovaleap®
timeFrame: 12 months
measure: Administered total dose of Ovaleap®
timeFrame: 12 months
measure: Level of serum estradiol at the time of the last examination prior to induction of ovulation
timeFrame: 12 months
measure: Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation
timeFrame: 12 months
measure: Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist)
timeFrame: 12 months
measure: Number of Metaphase II (MII)-oocytes
timeFrame: 12 months
measure: Percentage fertilisation rate
timeFrame: 12 months
measure: Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos
timeFrame: 12 months
measure: Luteal phase support (LPS): product, dose and duration of administration
timeFrame: 12 months
measure: User satisfaction with the Ovaleap®-pen
timeFrame: 12 months
measure: "Baby-Take-Home-Rate" (live-births).
timeFrame: 12 months
measure: Rate of multiple pregnancies (twins, triplets, quadruplets).
timeFrame: 12 months
measure: Frequency and intensity of adverse drug reactions (ADRs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Aalen
country: Germany
facility: Teva Investigational Site 034
state: Baden-Württemberg
city: Kempten
country: Germany
facility: Teva Investigational Site 033
state: Bayern
city: Munchen
country: Germany
facility: Teva Investigational Site 026
state: Bayern
city: Regensburg
country: Germany
facility: Teva Investigational Site 032
state: Bayern
city: Ludwigshafen
country: Germany
facility: Teva Investigational Site 035
state: Rheinland-Pfalz
city: Aalen
country: Germany
facility: Teva Investigational Site 036
city: Berlin
country: Germany
facility: Teva Investigational Site 004
city: Berlin
country: Germany
facility: Teva Investigational Site 015
city: Berlin
country: Germany
facility: Teva Investigational Site 017
city: Berlin
country: Germany
facility: Teva Investigational Site 027
city: Berlin
country: Germany
facility: Teva Investigational Site 031
city: Bielefeld
country: Germany
facility: Teva Investigational Site 022
city: Dortmund
country: Germany
facility: Teva Investigational Site 013
city: Düsseldorf
country: Germany
facility: Teva Investigational Site 003
city: Düsseldorf
country: Germany
facility: Teva Investigational Site 010
city: Essen
country: Germany
facility: Teva Investigational Site 011
city: Esslingen
country: Germany
facility: Teva Investigational Site 025
city: Großhansdorf
country: Germany
facility: Teva Investigational Site 012
city: Hamburg
country: Germany
facility: Teva Investigational Site 037
city: Hannover
country: Germany
facility: Teva Investigational Site 016
city: Hildesheim
country: Germany
facility: Teva Investigational Site 028
city: Kiel
country: Germany
facility: Teva Investigational Site 021
city: Leipzig
country: Germany
facility: Teva Investigational Site 029
city: Ludwigsburg
country: Germany
facility: Teva Investigational Site 014
city: Lübeck
country: Germany
facility: Teva Investigational Site 020
city: Magdeburg
country: Germany
facility: Teva Investigational Site 023
city: München
country: Germany
facility: Teva Investigational Site 006
city: München
country: Germany
facility: Teva Investigational Site 030
city: Münster
country: Germany
facility: Teva Investigational Site 018
city: Osnabrück
country: Germany
facility: Teva Investigational Site 009
city: Regensburg
country: Germany
facility: Teva Investigational Site 007
city: Rostock
country: Germany
facility: Teva Investigational Site 002
city: Saarbrücken
country: Germany
facility: Teva Investigational Site 008
city: Stuttgart
country: Germany
facility: Teva Investigational Site 019
city: Ulm
country: Germany
facility: Teva Investigational Site 005
city: Ulm
country: Germany
facility: Teva Investigational Site 024
city: Wiesbaden
country: Germany
facility: Teva Investigational Site 001
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.