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.

November 5, 2021 updated by: Teva Pharma GmbH

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

507

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aalen, Germany
        • Teva Investigational Site 036
      • Berlin, 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
      • Bielefeld, Germany
        • Teva Investigational Site 022
      • Dortmund, Germany
        • Teva Investigational Site 013
      • Düsseldorf, Germany
        • Teva Investigational Site 003
      • Düsseldorf, Germany
        • Teva Investigational Site 010
      • Essen, Germany
        • Teva Investigational Site 011
      • Esslingen, Germany
        • Teva Investigational Site 025
      • Großhansdorf, Germany
        • Teva Investigational Site 012
      • Hamburg, Germany
        • Teva Investigational Site 037
      • Hannover, Germany
        • Teva Investigational Site 016
      • Hildesheim, Germany
        • Teva Investigational Site 028
      • Kiel, Germany
        • Teva Investigational Site 021
      • Leipzig, Germany
        • Teva Investigational Site 029
      • Ludwigsburg, Germany
        • Teva Investigational Site 014
      • Lübeck, Germany
        • Teva Investigational Site 020
      • Magdeburg, Germany
        • Teva Investigational Site 023
      • München, Germany
        • Teva Investigational Site 006
      • München, Germany
        • Teva Investigational Site 030
      • Münster, Germany
        • Teva Investigational Site 018
      • Osnabrück, Germany
        • Teva Investigational Site 009
      • Regensburg, Germany
        • Teva Investigational Site 007
      • Rostock, Germany
        • Teva Investigational Site 002
      • Saarbrücken, Germany
        • Teva Investigational Site 008
      • Stuttgart, Germany
        • Teva Investigational Site 019
      • Ulm, Germany
        • Teva Investigational Site 005
      • Ulm, Germany
        • Teva Investigational Site 024
      • Wiesbaden, Germany
        • Teva Investigational Site 001
    • Baden-Württemberg
      • Aalen, Baden-Württemberg, Germany
        • Teva Investigational Site 034
    • Bayern
      • Kempten, Bayern, Germany
        • Teva Investigational Site 033
      • Munchen, Bayern, Germany
        • Teva Investigational Site 026
      • Regensburg, Bayern, Germany
        • Teva Investigational Site 032
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany
        • Teva Investigational Site 035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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).

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ovaleap®
Single group prospective treatment cohort
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of retrieved oocytes after ovarian stimulation therapy
Time Frame: 12 months
12 months
Clinical pregnancy rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days with administration of Ovaleap®
Time Frame: 12 months
12 months
Administered total dose of Ovaleap®
Time Frame: 12 months
12 months
Level of serum estradiol at the time of the last examination prior to induction of ovulation
Time Frame: 12 months
12 months
Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation
Time Frame: 12 months
12 months
Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist)
Time Frame: 12 months
12 months
Number of Metaphase II (MII)-oocytes
Time Frame: 12 months
12 months
Percentage fertilisation rate
Time Frame: 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.
12 months
Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos
Time Frame: 12 months
12 months
Luteal phase support (LPS): product, dose and duration of administration
Time Frame: 12 months
12 months
User satisfaction with the Ovaleap®-pen
Time Frame: 12 months
Patient Questionnaire completed by patient
12 months
"Baby-Take-Home-Rate" (live-births).
Time Frame: 12 months
12 months
Rate of multiple pregnancies (twins, triplets, quadruplets).
Time Frame: 12 months
12 months
Frequency and intensity of adverse drug reactions (ADRs)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Pharma GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2016

Primary Completion (Actual)

July 21, 2017

Study Completion (Actual)

March 13, 2018

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • XM17-WH-40103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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