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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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