NCT02809989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
507

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

June 20, 2016

Last Update Submit

November 5, 2021

Conditions

Pregnancy RateOocytes

Outcome Measures

Primary Outcomes (2)

  • Number of retrieved oocytes after ovarian stimulation therapy

    12 months

  • Clinical pregnancy rate

    12 months

Secondary Outcomes (13)

  • 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

    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

  • +8 more secondary outcomes

Study Arms (1)

Ovaleap®

Single group prospective treatment cohort

Drug: Ovaleap®

Interventions

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).

Ovaleap®

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Teva Investigational Site 034

Aalen, Baden-Wurttemberg, Germany

Location

Teva Investigational Site 033

Kempten (Allgäu), Bavaria, Germany

Location

Teva Investigational Site 026

München, Bavaria, Germany

Location

Teva Investigational Site 032

Regensburg, Bavaria, Germany

Location

Teva Investigational Site 035

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Location

Teva Investigational Site 036

Aalen, Germany

Location

Teva Investigational Site 004

Berlin, Germany

Location

Teva Investigational Site 015

Berlin, Germany

Location

Teva Investigational Site 017

Berlin, Germany

Location

Teva Investigational Site 027

Berlin, Germany

Location

Teva Investigational Site 031

Berlin, Germany

Location

Teva Investigational Site 022

Bielefeld, Germany

Location

Teva Investigational Site 013

Dortmund, Germany

Location

Teva Investigational Site 003

Düsseldorf, Germany

Location

Teva Investigational Site 010

Düsseldorf, Germany

Location

Teva Investigational Site 011

Essen, Germany

Location

Teva Investigational Site 025

Esslingen am Neckar, Germany

Location

Teva Investigational Site 012

Großhansdorf, Germany

Location

Teva Investigational Site 037

Hamburg, Germany

Location

Teva Investigational Site 016

Hanover, Germany

Location

Teva Investigational Site 028

Hildesheim, Germany

Location

Teva Investigational Site 021

Kiel, Germany

Location

Teva Investigational Site 029

Leipzig, Germany

Location

Teva Investigational Site 014

Ludwigsburg, Germany

Location

Teva Investigational Site 020

Lübeck, Germany

Location

Teva Investigational Site 023

Magdeburg, Germany

Location

Teva Investigational Site 006

München, Germany

Location

Teva Investigational Site 030

München, Germany

Location

Teva Investigational Site 018

Münster, Germany

Location

Teva Investigational Site 009

Osnabrück, Germany

Location

Teva Investigational Site 007

Regensburg, Germany

Location

Teva Investigational Site 002

Rostock, Germany

Location

Teva Investigational Site 008

Saarbrücken, Germany

Location

Teva Investigational Site 019

Stuttgart, Germany

Location

Teva Investigational Site 005

Ulm, Germany

Location

Teva Investigational Site 024

Ulm, Germany

Location

Teva Investigational Site 001

Wiesbaden, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32456636DERIVED

Study Officials

  • Teva Medical Expert, MD

    Teva Branded Pharmaceutical Products R&D, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

March 31, 2016

Primary Completion

July 21, 2017

Study Completion

March 13, 2018

Last Updated

November 9, 2021

Record last verified: 2021-11

Locations

DE(37)