Comfort, ease of use and practicality of the pen injector for follitropin α for assisted reproduction: an observational post-marketing study in Egypt

Abstract

Objective:

We evaluated the ease of use of a pen injector for follitropin α (recombinant human follicle-stimulating hormone [r-hFSH]) during assisted reproduction technologies (ARTs) in Egypt.

Methods:

One hundred women undergoing ART completed a questionnaire in a non-interventional, observational study. The primary endpoint was patients’ rating of the comfort associated with the injector. The main limitations of the study were the design and lack of knowledge regarding any impact of failure of ART on perceptions of treatment for a minority of patients.

Results:

Patients rated the follitropin α pen injector as ‘very comfortable’ (61%), ‘comfortable’ (29%), or ‘somewhat comfortable’ (10%). Understanding instructions and using it were ‘very easy’ or ‘easy’ for 97–99%; 94% reported ‘no’ or ‘minimal’ difficulty with injections, 83% were ‘very confident’ about altering doses, 77% reported no interference with normal daily activities and 94% reported ‘no’ or ‘minimal’ stress using the device. Women with previous experience of ART rated the device as more practical than their previous injection system. Overall, 96% were ‘very satisfied’ or ‘satisfied’ with the device and 99% would recommend its use to others. Pregnancy rates were consistent with previous clinical experience. Injection site reactions occurred in 10% (all of mild severity except one moderate event).

Conclusions:

Positive perceptions of the follitropin α pen injector identify this device as suitable for use for Middle Eastern women undergoing ART.

Keywords::

• Assisted reproduction technologies
• Follitropin α
• Patient-reported outcomes
• Recombinant human follicle-stimulating hormone

Transparency

Declaration of funding

The study was funded by an educational grant from Merck Ltd Egypt, an affiliate of Merck KGaA, Darmstadt, Germany. No payment was made to patients, although the follitropin α pens were provided free of charge as part of the study protocol.

Declaration of financial/other relationships

M.Y., W.E.-K., A.K., A.H.M., A.A.A.K., A.A. and S.K. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors are grateful to Dr Bassem Sadek MSc MBBCH and Dr Hala Mansour PhD, of Merck Serono, for their valuable contributions to the design and implementation of the study and to the development of the manuscript. The authors would also like to thank sub-investigators, study nurses and recruited patients at both Assisted Reproduction Technologies Units: Ain Shams University and the IVF Center, Cairo University. A medical writer (Dr Mike Gwilt, GT Communications) provided editorial assistance in the preparation of this manuscript, funded by Merck Serono.