Completed

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.

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 18 to 40 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2016
See protocol details

Summary

Principal SponsorTeva Pharma GmbH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 31, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleMulticentre, 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.
NCT02809989
Principal SponsorTeva Pharma GmbH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

507 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 37 locations

Suspended

Teva Investigational Site 034

Aalen, GermanyOpen Teva Investigational Site 034 in Google Maps
Suspended

Teva Investigational Site 033

Kempten (Allgäu), Germany
Suspended

Teva Investigational Site 026

München, Germany
Suspended

Teva Investigational Site 032

Regensburg, Germany
Completed37 Study Centers