Safety of Ovaleap® (Follitropin alfa) in Infertile Women Undergoing Superovulation for Assisted Reproductive Technologies. A Multi-National, Comparative, Prospective, Non-Interventional, Observational Cohort Study (SOFIA)

First published 19/01/2017

Last updated 23/04/2024

EU PAS number:

EUPAS17328

Study

Finalised

Documents

Study protocol

Initial protocol

Protocol _27-Oct-2016

English (474.85 KB - PDF)View document

Study results

Clinical Study Report_31-Jul-2020_1

English (1.93 MB - PDF)View document

OVALEAP CSR Addendum Updated Final 30Dec20

English (777.75 KB - PDF)View document

Study report

Other information

Study, other information

Protocol Letter of Clarification 01 XM17-WH-50005 Classification

English (1006.56 KB - PDF)View document

Protocol Letter of Clarification XM17-WH-50005_18Nov2019

English (594.04 KB - PDF)View document

ENCePP Seal

ENCePP Seal documents

Secondary tabs