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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.

NCT02809989 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 507

Last updated 2021-11-09

No results posted yet for this study

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.

Conditions

  • Pregnancy Rate
  • Oocytes

Interventions

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).

Sponsors & Collaborators

  • Teva Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-07-21
Completion
2018-03-13

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02809989 on ClinicalTrials.gov