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Pregnancy RateNCT02809989

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.

An observational study of Pregnancy Rate and Oocytes, run by Teva Pharma GmbH at 37 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Pregnancy Rate, Oocytes
What is being tested?
Ovaleap®
How many people
507 participants
Where
37 sitesGermany
Study dates
31 Mar 2016to 13 Mar 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Germany37 sites

  • Teva Investigational Site 034

    Aalen, Baden-Wurttemberg

  • Teva Investigational Site 036

    Aalen

  • Teva Investigational Site 004

    Berlin

  • Teva Investigational Site 015

    Berlin

  • Teva Investigational Site 017

    Berlin

  • Teva Investigational Site 027

    Berlin

  • Teva Investigational Site 031

    Berlin

  • Teva Investigational Site 022

    Bielefeld

  • Teva Investigational Site 013

    Dortmund

  • Teva Investigational Site 003

    Düsseldorf

  • Teva Investigational Site 010

    Düsseldorf

  • Teva Investigational Site 011

    Essen

  • Teva Investigational Site 025

    Esslingen am Neckar

  • Teva Investigational Site 012

    Großhansdorf

  • Teva Investigational Site 037

    Hamburg

  • Teva Investigational Site 016

    Hanover

  • Teva Investigational Site 028

    Hildesheim

  • Teva Investigational Site 033

    Kempten (Allgäu), Bavaria

  • Teva Investigational Site 021

    Kiel

  • Teva Investigational Site 029

    Leipzig

  • Teva Investigational Site 020

    Lübeck

  • Teva Investigational Site 014

    Ludwigsburg

  • Teva Investigational Site 035

    Ludwigshafen am Rhein, Rhineland-Palatinate

  • Teva Investigational Site 023

    Magdeburg

  • Teva Investigational Site 026

    München, Bavaria

  • Teva Investigational Site 006

    München

  • Teva Investigational Site 030

    München

  • Teva Investigational Site 018

    Münster

  • Teva Investigational Site 009

    Osnabrück

  • Teva Investigational Site 032

    Regensburg, Bavaria

  • Teva Investigational Site 007

    Regensburg

  • Teva Investigational Site 002

    Rostock

  • Teva Investigational Site 008

    Saarbrücken

  • Teva Investigational Site 019

    Stuttgart

  • Teva Investigational Site 005

    Ulm

  • Teva Investigational Site 024

    Ulm

  • Teva Investigational Site 001

    Wiesbaden

Other trials in Germany

About this study

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.

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.

Being tested
Ovaleap®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT02809989
Study groupRoleWhat they receive
Ovaleap®Single group prospective treatment cohort
Receives: Drug: Ovaleap®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of retrieved oocytes after ovarian stimulation therapy

    Measured: 12 months

  2. Clinical pregnancy rate

    Measured: 12 months

Secondary outcomes (13)

  1. Number of days with administration of Ovaleap®

    Measured: 12 months

  2. Administered total dose of Ovaleap®

    Measured: 12 months

  3. Level of serum estradiol at the time of the last examination prior to induction of ovulation

    Measured: 12 months

  4. Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation

    Measured: 12 months

  5. Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist)

    Measured: 12 months

  6. Number of Metaphase II (MII)-oocytes

    Measured: 12 months

  7. Percentage fertilisation rate

    • 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.

    Measured: 12 months

  8. Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos

    Measured: 12 months

  9. Luteal phase support (LPS): product, dose and duration of administration

    Measured: 12 months

  10. User satisfaction with the Ovaleap®-pen

    Patient Questionnaire completed by patient

    Measured: 12 months

  11. "Baby-Take-Home-Rate" (live-births).

    Measured: 12 months

  12. Rate of multiple pregnancies (twins, triplets, quadruplets).

    Measured: 12 months

  13. Frequency and intensity of adverse drug reactions (ADRs)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2016 (estimated)
  2. Study start31 Mar 2016
  3. Primary completion21 Jul 2017
  4. Study completion13 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02809989
Sponsor's protocol ID
XM17-WH-40103
Status last verified
Nov 2021
First submitted
20 Jun 2016
Last updated
9 Nov 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32456636

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy Rate and Oocytes, run by Teva Pharma GmbH at 37 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of retrieved oocytes after ovarian stimulation therapy (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02809989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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