NCT02809989

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.

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 507 (actual)
• Sponsor: Teva Pharma GmbH · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2016-03-31
• Primary completion: 2017-07-21
• Completion: 2018-03-13
• First posted: 2016-06-22
• Last updated: 2021-11-09

Locations

37 sites across 1 country: Germany